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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82889

41 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 21, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Torrent Pharma Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

41 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 41

RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

D-1345-2019
Recall number
D-1345-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
48,955 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 18F020, Exp. 06/2020; 18H013, Exp. 08/2020; 18J015, Exp. 09/2020; 18K015, 18K034, Exp. 10/2020; 19A014, Exp. 01/2021

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 2 of 41

Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.

D-1346-2019
Recall number
D-1346-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
58,272 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #: 17E035, Exp. 05/2019

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 3 of 41

Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.

D-1347-2019
Recall number
D-1347-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
118,080 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E019; 17E045, Exp. 05/2019

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 4 of 41

Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1348-2019
Recall number
D-1348-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
2,646,228 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17E003; 17E038, Exp. 05/2019; 17F002; 17F005; 17F007; 17F025, Exp. 06/2019; 17G014, Exp. 07/2019; 17H015, Exp. 08/2019; 17J004; 17J006; 17J016, Exp. 09/2019; 17K008; 17K013; 17K021; 17K027, Exp. 10/2019; 17L021, Exp. 11/2019; 17M032, Exp. 12/2019; 18A023; 18A039, Exp. 01/2020; 18B007; 18B030; 18B037, Exp. 02/2020; 18C017; 18C026, Exp. 03/2020; 18D003; 18D034, Exp. 04/2020; 18E027; 18E033, Exp. 05/2020; 18F024; 18F033, Exp. 06/2020; 18G001; 18G023, Exp. 07/2020; 18J008; 18J009; 18J017; 18J027, Exp. 09/2020; 18K013; 18K014; 18K028, Exp. 10/2020. b) 17E006; 17E008, Exp. 05/2019; 17G001; 17G008;17G025, Exp. 07/2019; 17J022, Exp. 09/2019; 17K001; 17K007; 17K007A, Exp. 10/2019; 17L014, 17L034, Exp. 11/2019; 18A007; 18A007A, Exp. 01/2020; 18A025; 18A036, Exp. 01/2020; 18B018; 18B033; 18B034, Exp. 02/2020; 18D032; 18D035, Exp. 04/2020; 18E006; 18E035; 18E036, Exp. 05/2020; 18F033; 18F034, Exp. 06/2020; 18G007; 18G019, Exp. 07/2020; 18H008; 18H009; 18H025, Exp. 08/2020; 19A002, Exp. 01/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 5 of 41

Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1349-2019
Recall number
D-1349-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
984,888 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17F003, Exp. 06/2019; 17J011, Exp. 09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A035; Exp. 01/2020; 18B022; 18B027, Exp. 02/2020; 18C036, Exp. 03/2020; 18D009; 18D024, Exp. 04/2020. b) 17G018, Exp. 07/2019; 17H001; 17H010; 17H014, Exp. 08/2019; 17J009, Exp. 09/2019; 17K023, Exp. 10/2019; 17L006; 17L025, Exp. 11/2019; 17M025; 17M034; Exp. 12/2019; 18A005; 18A012; 18A016, Exp. 01/2020; 18B020, Exp. 02/2020; 18C023; 18C031, Exp. 03/2020; 18E017, Exp. 05/2020; 18G005; 18G022, Exp. 07/2020; 18H021; 18H026, Exp. 08/2020; 18J003Exp. 09/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 6 of 41

Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

D-1350-2019
Recall number
D-1350-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
131,328 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17M003, Exp. 12/2019; 18A009; 18A010, Exp. 01/2020; 18B024, Exp. 02/2020; 18F021; Exp. 06/2020; 18G009; 18G020, Exp. 07/2020; 18K005; 18K011; Exp. 10/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 7 of 41

Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

D-1351-2019
Recall number
D-1351-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
1,500,672 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17F001, Exp. 06/2019; 17G016, Exp. 07/2019; 17H017, Exp. 08/2019;17L002; 17L024, Exp. 11/2019; 17M010; 17M013, Exp. 12/2019; 18B006; 18B031, Exp. 02/2020; 18C033, Exp. 03/2020; 18D015; 18D016, Exp. 04/2020; 18E020, Exp. 05/2020; 18G013, Exp. 07/2020; 18L010, Exp. 11/2020; 19A010; 19A019, Exp. 01/2021 b) 17F015, Exp. 06/2019; 17L009, Exp. 11/2019; 17M012, Exp. 12/2019; 18B015, Exp. 02/2020; 18C034, Exp. 03/2020; 18E026, Exp. 05/2020; 18G011, Exp. 08/2020. c) 17E014, Exp. 05/2019; 17G009;17G020, Exp. 07/2019; 17K019, Exp. 10/2019; 17L012; 17L013, Exp. 11/2019; 17M016; 17M033, Exp. 12/2019; 18A002, Exp. 01/2020; 18B009; 18B019, Exp. 02/2020; 18C015; 18C035, Exp. 03/2020; 18D001; 18D002, Exp. 04/2020; 18E018, Exp. 05/2020; 18F027, Exp. 06/2020; 18H017; 18H018, Exp. 08/2020; 18K016; 18K035, Exp. 10/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 8 of 41

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1352-2019
Recall number
D-1352-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
655,104 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a)17E018; 17E020, 17E026, Exp. 05/2019; 17H008; 17H018; 17H028, Exp. 08/2019; 17J002; 17J025; 17J028, Exp. 09/2019; 17L035, Exp. 11/2019; 17M024, Exp. 12/2019; 18A017, Exp. 01/2020; 18B016, Exp. 02/2020; 18C011, Exp. 03/2020; 18D014; 18D021; 18D026, Exp. 04/2020; 18E014, Exp. 05/2020; 18F036, Exp. 06/2020; 18F035; 18G018, Exp. 07/2020; 18H005; 18H015, Exp. 08/2020; 19A011; 19A013, Exp. 01/2121. b) 17E013; 17E025; 17E028; 17E041, Exp. 05/2019; 17F009; 17F016, Exp. 06/2019; 17G007; 17G021; 17G032, Exp. 07/2019; 17H023, Exp. 08/2019; 17J001; 17J012; 17J023; 17J027, Exp. 09/2019; 17K004; 17K022; 17K028; 17K028A, Exp. 10/2019; 17L032; Exp. 11/2019; 17M036, Exp. 12/2019; 18A011; 18A019; 18A030; 18A032; 18A041, Exp. 01/2020; 18B010; 18B038, Exp. 02/2020; 18C008; 18C022; 18C030, Exp. 03/2020; 18D004; 18D008; 18D010; 18D011, Exp. 04/2020; 18F028; 18H010, Exp. 06/2020; 18G004; 18G012, Exp. 07/2020; 18H002; 18H011; 18H027; 18H032; 18H033, Exp. 08/2020; 18K008; 18K009, Exp. 10/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 9 of 41

Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.

D-1353-2019
Recall number
D-1353-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
1,436,904 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17H012, Exp. 08/2019; 17L011, Exp. 11/2019; 17M020, Exp. 12/2019; 18D007, Exp. 04/2020; 18J001, Exp. 09/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 10 of 41

Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1354-2019
Recall number
D-1354-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
3,788,502 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17E032, Exp. 05/2019; 17F011; 17F020, Exp. 06/2019; 17G003; 17G011, Exp. 07/2019; 17H016, Exp. 08/2019; 17J005; 17J017; 17J026, Exp. 09/2019; 17K029, Exp. 10/2019; 17L027, Exp. 11/2019; 18A003; 18A004; 18A033, Exp. 01/2020; 18B011, Exp. 02/2020; 18C029, Exp. 03/2020; 18D019; 18D025, Exp. 04/2020; 18F014, Exp. 06/2020; 18H029, Exp. 08/2020; 18J007; 18J018, Exp. 09/2020; 18K007; 18K026, Exp. 10/2020; 19A012, Exp. 01/2021. b) 17E011, Exp. 05/2019; 17E012, Exp. 06/2019; 17G019; 17G023, Exp. 07/2019; 17H011, Exp. 08/2019; 17J029, Exp. 09/2019; 17K005, Exp. 10/2019; 17M005; 17M018, Exp. 12/2019; 18C001; 18C004, Exp. 03/2020; 18F032; 18F019, Exp. 06/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 11 of 41

Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1355-2019
Recall number
D-1355-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
262,008 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E016; 17E017, Exp. 05/2019; 17F023; 17F023A, Exp. 06/2019; 17L018; 17L029; 17L030; 17L031, Exp. 11/2019; 17M035, Exp. 12/2019; 18B002; 18B014; 18B035, Exp. 02/2020; 18C002; 18C019, Exp. 03/2020; 18D013, Exp. 04/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 12 of 41

Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1356-2019
Recall number
D-1356-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
17,748 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17L020, Exp. 11/2019; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 13 of 41

Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

D-1357-2019
Recall number
D-1357-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
391,404 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17E004; 17E033, Exp. 05/2019; 17F019, Exp. 06/2019; 17G017, Exp. 07/2019; 17K009; 17K030; Exp. 10/2019, 17M006; 17M028, Exp. 12/2019; 18A029, Exp. 01/2020; 18C037, Exp. 03/2020; 18E002, Exp. 05/2020; 18F003; 18F013, Exp. 06/2020; 18G002; 18G016, Exp. 07/2020; 18H031, Exp. 08/2020; 18J004, 09/2020; 18L008; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17E005; 17E027, Exp. 05/2019; 17K025, Exp. 10/2019; 17M006, Exp. 12/2019; 18A014, Exp. 01/2020; 18B039, Exp. 02/2020; 18C037, Exp. 03/2020; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020; 18F013; 18F018, Exp. 06/2020; 18G003, Exp. 07/2020; 18H012; 18H014, Exp. 08/2020; 18J026, Exp. 09/2020; 18L009, Exp. 11/2020; 18M014, Exp. 12/2020; 19A021, Exp. 01/2021; 19B001; 19B002, Exp. 02/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 14 of 41

Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.

D-1358-2019
Recall number
D-1358-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
66,798 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17L003, Exp. 05/2019; 18A021, Exp. 07/2019; 18C027, Exp. 09/2019; 18D020, Exp. 10/2019; 18E007, 18E022, Exp. 11/2019; 18F006; 18F007; 18F023; 18F023A; 18F040, Exp. 12/2019; 19A004, Exp. 07/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 15 of 41

Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.

D-1359-2019
Recall number
D-1359-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
53,520 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E039, Exp. 05/2019; 17K016, Exp. 10/2019; 18E021, Exp. 05/2020; 18G008, Exp. 07/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 16 of 41

Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.

D-1360-2019
Recall number
D-1360-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
24,384 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17F021, Exp. 06/2019; 17G013, Exp. 07/2019; 17K010, Exp. 10/2019; 18E015, Exp. 05/2020; 18F029; 18F031; 18F042, Exp. 06/2020; 18G024, Exp. 07/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 17 of 41

Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

D-1361-2019
Recall number
D-1361-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
361,260 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E015; 17E024; 17E044, Exp. 05/2019; 17F018, Exp. 06/2019; 17G012, Exp. 07/2019; 17K024, Exp. 10/2019; 17M004, Exp. 12/2019; 18B017, Exp. 02/2020; 18H023, Exp. 08/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 18 of 41

Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.

D-1362-2019
Recall number
D-1362-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
14,016 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 18J005; 18J016; 18J025, Exp. 09/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 19 of 41

Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663

D-1363-2019
Recall number
D-1363-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
233,388 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17H002; 17H005; 17H006; 17H007; 17H026; 17H027, Exp. 08/2019; 17J010; 17J013, Exp. 09/2019; 17K014; 17K015, Exp. 10/2019; 17L015, Exp. 11/2019; 17M026, Exp. 12/2019; 18A028; 18A031, Exp. 01/2020; 18B026, Exp. 02/2020; 18E003, Exp. 05/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 20 of 41

Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401.

D-1364-2019
Recall number
D-1364-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
6,000 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E031, Exp. 05/2019; 18F030, Exp. 06/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 21 of 41

Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.

D-1365-2019
Recall number
D-1365-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
148,440 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E007, Exp. 05/2019; 17F026, Exp. 06/2019; 17G015, Exp. 07/2019; 17K002; 17K026, Exp. 10/2019; 17M002, Exp. 12/2019; 18C020, Exp. 03/2020; 18D023, Exp. 04/2020; 18F009, Exp. 06/2020; 18K030, Exp. 10/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 22 of 41

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.

D-1366-2019
Recall number
D-1366-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
1,883,796 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17E022; 17E037, Exp. 05/2019; 17G006; 17G026, Exp. 07/2019; 17H019; 17H020, Exp. 08/2019; 17J020, Exp. 09/2019; 17K006; 17K012, Exp. 10/2019; 17L028; 17L033, Exp. 11/2019; 18A001; 18A006; 18A013; 18A038, Exp. 01/2020; 18B036, Exp. 02/2020; 18C024, Exp. 03/2020; 18E009; 18E019; 18E028, Exp. 05/2020; 18F010, Exp. 06/2020; 18H003, Exp. 08/2020; 18J010; 18J012; 18J013; 18J019, Exp. 09/2020; 18K003; 18K012, Exp. 10/2020; 19A016, Exp. 01/2021. b) 17E036, Exp. 05/2019; 17F008; 17F008A, Exp. 06/2019; 17H030, Exp. 08/2019; 17K017, Exp. 10/2019; 17L017, Exp. 11/2019; 17M031, Exp. 12/2019; 18A020; 18A040, Exp. 01/2020; 18B036, Exp. 02/2020; 18C032, Exp. 03/2020; 18E004; 18E032, Exp. 05/2020; 18F001, Exp. 06/2020; 18H006, Exp. 08/2020; 18K032, Exp. 10/2020; 18L003, Exp. 11/2020; 19A007, Exp. 01/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 23 of 41

Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.

D-1367-2019
Recall number
D-1367-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
66,060 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E009, Exp. 05/2019; 17L004; 17L004A, 17L020, Exp. 11/2019; 17M029, Exp. 12/2019; 18C010; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 24 of 41

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

D-1368-2019
Recall number
D-1368-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
249,744 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17F022, Exp. 06/2019; 17G027, Exp. 07/2019; 17H021; 17H021A, Exp. 08/2019; 17J008, Exp. 09/2019; 17L001, Exp. 11/2019; 17M015, Exp. 12/2019; 18A018, Exp. 01/2020; 18B003; 18B008, Exp. 02/2020; 18C012, Exp. 03/2020; 18D005, Exp. 04/2020; 18F008; 18F043, Exp. 06/2020; 18G025; 18H004, Exp. 07/2020; 18H007; 18H016, Exp. 08/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 25 of 41

Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

D-1369-2019
Recall number
D-1369-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
176,580 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E034, Exp. 05/2019; 17L023, Exp. 11/2019; 17M027; 17M027A, Exp. 12/2019; 18A024, Exp. 01/2020; 18B029, Exp. 02/2020; 18C018; 18C021, Exp. 03/2020; 18E008, Exp. 05/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 26 of 41

Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

D-1370-2019
Recall number
D-1370-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
438,624 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17H025, Exp. 08/2019; 17M022, Exp. 12/2019; 18E011, Exp. 05/2020; 18G018, Exp. 07/2020; 18J014, Exp. 09/2020. b) 17E010; 17E030, Exp. 05/2019; 17F013, Exp. 06/2019; 17F010, Exp. 07/2019; 17J014, Exp. 09/2019; 17L005, Exp. 11/2019; 17M017, Exp. 12/2019; 18A022, Exp. 01/2020; 18B021, Exp. 02/2020 18D017, Exp. 04/2020; 18E011, Exp. 05/2020; 18F041, Exp. 06/2020; 18G021; 18H022; 18H028; 18H030, Exp. 08/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 27 of 41

Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.

D-1371-2019
Recall number
D-1371-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
62,748 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17G002, Exp. 07/2019; 17H024, Exp. 08/2019; 17M023, Exp. 12/2019; 18F012, Exp. 06/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 28 of 41

Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

D-1372-2019
Recall number
D-1372-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
96,060 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 18K025; 18K027, Exp. 10/2020; 18L001; 18L006; 18L007, Exp. 11/2020; 18M013, Exp. 12/2020; 19A006, Exp. 01/2021. b) 18K027, Exp. 10/2020; 19A006, Exp. 01/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 29 of 41

Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

D-1373-2019
Recall number
D-1373-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
153.540 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 18E016; 18E029, Exp. 05/2020; 18F004; 18F005; 18F039, Exp. 06/2020; 18G010; 18G017, Exp. 07/2020; 18H019, Exp. 08/2020; 18M008, Exp. 12/2020; 19A005, Exp. 01/2021; 19B010, Exp. 02/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 30 of 41

Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

D-1374-2019
Recall number
D-1374-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
5,681 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E001, Exp. 05/2019; 17F014, Exp. 06/2019; 17G005; 17G010, Exp. 07/2019; 17J019; 17J021, Exp. 09/2019; 17M008; 17M009, Exp. 12/2019.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 31 of 41

Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

D-1375-2019
Recall number
D-1375-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
264 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #: 18F026, Exp. 06/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 32 of 41

Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.

D-1376-2019
Recall number
D-1376-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
140,436 suppositories

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17L010, Exp. 11/2019; 18D018, Exp. 04/2020; 18F022; 18F022A, Exp. 06/2020. b) 17L019; 17L026, Exp. 11/2019; 18B005, Exp. 02/2020; 18D006, 18D012; 18D022, Exp. 04/2020; 18K006, Exp. 10/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 33 of 41

Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.

D-1377-2019
Recall number
D-1377-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
120,204 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) 17K009, Exp. 10/2019; 17M028, Exp. 12/2019; 18F003, Exp. 06/2020; 18J022, Exp. 09/2020; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17G004; 17G028, Exp. 07/2019; 18A034, Exp. 01/2020; 18C016, Exp. 03/2020; 18E005, Exp. 05/2020; 18F038, Exp. 06/2020; 18G015, Exp. 07/2020; 18H024, Exp. 08/2020; 18K024, Exp. 10/2020; 18L011, Exp. 11/2020; 19A009, Exp. 01/2021; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 34 of 41

Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.

D-1378-2019
Recall number
D-1378-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
82,872 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17L008, Exp. 05/2019; 17M019; 17M037, Exp. 06/2019; 18B012; 18K023, Exp. 04/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 35 of 41

Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.

D-1379-2019
Recall number
D-1379-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
177,408 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17L008, Exp. 05/2019; 17M011; 17M037, Exp. 06/2019; 18A015, Exp. 07/2019; 18B012; 18B023, Exp. 08/2019; 18K023; 18K029, Exp. 04/2020; 18L014, Exp. 05/2020; 19A001, Exp. 06/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 36 of 41

Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.

D-1380-2019
Recall number
D-1380-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
1,126,404 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17E021; 17E023; 17E040; 17E042, Exp. 05/2019; 17F017, Exp. 06/2019; 17G030; 17G033, Exp. 07/2019; 17H013, Exp. 08/2019; 17J007; 17J024, Exp. 09/2019; 17K003; 17K011, Exp. 10/2019; 17L016; 17L022, Exp. 11/2019; 17M001; 17M021; 17M030, Exp. 12/2019; 18A027; 18A037, Exp. 01/2020; 18B001, Exp. 02/2020; 18C005; 18C006; 18C007, Exp. 03/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 37 of 41

Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..

D-1381-2019
Recall number
D-1381-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
730,476 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: a) Lot #: 18D027, 18D028, 18D029; Exp. 04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020; 18F016A; 18F017A; 18F037A, Exp. 06/2020; 18J021; 18J023; 18J023A; 18J024, Exp. 09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 38 of 41

RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.

D-1382-2019
Recall number
D-1382-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
52,368 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17F012; 17F012A, Exp. 06/2019; 17G031, Exp. 07/2019; 17H004; 17H031, Exp. 08/2019; 18B004, Exp. 02/2020; 18C028, Exp. 03/2020

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 39 of 41

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.

D-1383-2019
Recall number
D-1383-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
11,112 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 18B013, Exp. 02/2020; 18E024; 18E030, Exp. 05/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 40 of 41

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.

D-1384-2019
Recall number
D-1384-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
7,728 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

drug · product 41 of 41

Bisacodyl Suppositories, Brite Stock, Reese.

D-1385-2019
Recall number
D-1385-2019
Initiated
May 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Torrent Pharma Inc
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information

Lot #s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp. 05/2020.

Distribution pattern

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.