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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84978

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

Open FDA event record

Event summary

Timeline bucket
January 15, 2020
Product types
Drug
Classifications
Class II and Class III
Statuses
Terminated
Recalling firm wording
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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

63 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 63

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2

D-0932-2020
Recall number
D-0932-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 12042019+533247, Exp 1/17/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 2 of 63

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2

D-0933-2020
Recall number
D-0933-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 12042019+533225, Exp 1/17/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 3 of 63

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2

D-0934-2020
Recall number
D-0934-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 12042019+53323, Exp 1/17/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 4 of 63

Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2

D-0935-2020
Recall number
D-0935-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 12042019+53331, Exp 1/17/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 5 of 63

Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2

D-0936-2020
Recall number
D-0936-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11112019+53208, Exp 4/29/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 6 of 63

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2

D-0937-2020
Recall number
D-0937-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11112019+53210, Exp 4/4/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 7 of 63

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2

D-0938-2020
Recall number
D-0938-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11112019+53214, Exp 3/5/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 8 of 63

AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3

D-0939-2020
Recall number
D-0939-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07112019+52635, Exp 1/17/2020; 09092019+52890, Exp 3/17/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 9 of 63

AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5

D-0940-2020
Recall number
D-0940-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 08222019+52828, Exp 2/28/2020; 09092019+52889, Exp 3/17/2020; 09182019+52924, Exp 3/26/2020; 09262019+52971, Exp 4/3/2020; 10142019+53108, Exp 4/21/2020; 10212019+53136, Exp 4/28/2020; 10302019+53164, Exp 5/7/2020; 11252019+53278, Exp 6/2/2020; 11262019+53284, Exp 6/3/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 10 of 63

B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3

D-0941-2020
Recall number
D-0941-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07022019+52584, 07022019+52579, Exp 3/29/2020; 08012019+52780, 08012019+52782, Exp 4/28/2020; 11262019+53288, Exp 8/23/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 11 of 63

BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0620-2

D-0942-2020
Recall number
D-0942-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10022019+53004, Exp 2/28/2020; 11252019+53282, Exp 6/12/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 12 of 63

BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1

D-0943-2020
Recall number
D-0943-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07092019+52610, Exp 2/6/2020; 07232019+52734, Exp 2/19/2020; 08282019+52853, 09042019+52878, 09102019+52903, Exp 3/2/2020; 09182019+52929, Exp 4/17/2020; 10092019+53082, Exp 2/28/2020, 10152019+53124; Exp 5/4/2020; 10222019+53142, Exp 2/28/2020; 10292019+53160, 11052019+53186, Exp 5/4/2020; 11202019+53257, Exp 6/19/2020; 11212019+53270, Exp 6/20/2020; 12042019+53317, Exp 7/3/2020; 12102019+53363, Exp 7/9/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 13 of 63

BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well. 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-5

D-0944-2020
Recall number
D-0944-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07232019+52738, Exp 2/20/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 14 of 63

Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3

D-0945-2020
Recall number
D-0945-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11132019+53229, Exp 2/10/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 15 of 63

Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3

D-0946-2020
Recall number
D-0946-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10302019+53166, Exp 2/15/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 16 of 63

Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1

D-0947-2020
Recall number
D-0947-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 06032019+52353, Exp 7/29/2020; 07082019+52596, Exp 9/2/2020; 10012019+52986, Exp 8/12/2020; 12122019+53374, Exp 1/25/2021

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 17 of 63

Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3

D-0948-2020
Recall number
D-0948-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #:07172019+52695, 07172019+52697, 07252019+52759, Exp 1/25/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 18 of 63

Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3

D-0949-2020
Recall number
D-0949-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 09252019+52967, Exp 4/4/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 19 of 63

Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3

D-0950-2020
Recall number
D-0950-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10082019+53080, Exp 6/30/2020; 11192019+53251, Exp 8/24/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 20 of 63

Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1

D-0951-2020
Recall number
D-0951-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10022019+53002, Exp 10/1/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 21 of 63

Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3

D-0952-2020
Recall number
D-0952-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07242019+52740, Exp 1/20/2020; 11202019+53259, Exp 5/18/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 22 of 63

Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3

D-0953-2020
Recall number
D-0953-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10212019+53138, Exp 11/19/2020; 10302019+53172, Exp 1/28/2020; 11122019+53225, Exp 2/10/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 23 of 63

Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1

D-0954-2020
Recall number
D-0954-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 08142019+52805, Exp 2/10/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 24 of 63

Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3

D-0955-2020
Recall number
D-0955-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07012019+52572, Exp 4/6/2020; 10102019+53106, Exp 6/30/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 25 of 63

Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1

D-0956-2020
Recall number
D-0956-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07222019+52720, Exp 1/28/2020; 09182019+52923, Exp 3/26/2020; 10232019+53148, Exp 2/28/2020; 11142019+53243, Exp 5/22/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 26 of 63

Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0339-3

D-0957-2020
Recall number
D-0957-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11042019+53179, Exp 2/18/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 27 of 63

Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5

D-0958-2020
Recall number
D-0958-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07302019+52772, Exp 2/25/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 28 of 63

Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3

D-0959-2020
Recall number
D-0959-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10242019+53154, Exp 1/22/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 29 of 63

Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3

D-0960-2020
Recall number
D-0960-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10152019+53126, Exp 4/6/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 30 of 63

Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3

D-0961-2020
Recall number
D-0961-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 08212019+52824, Exp 2/17/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 31 of 63

Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5

D-0962-2020
Recall number
D-0962-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07012019+52569, Exp 3/15/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 32 of 63

Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3

D-0963-2020
Recall number
D-0963-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10222019+53144, Exp 1/27/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 33 of 63

Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5

D-0964-2020
Recall number
D-0964-2020
Initiated
January 15, 2020
Classification
Class III
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10292019+53156, Exp 4/26/2020; 11182019+53247, Exp 5/16/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 34 of 63

Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3

D-0965-2020
Recall number
D-0965-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 09052019+52881, Exp 4/7/2020; 09302019+52977, Exp 5/2/2020; 10072019+53049, Exp 5/9/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 35 of 63

Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3

D-0966-2020
Recall number
D-0966-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07292019+52764, Exp 1/25/2020; 07292019+52766, Exp 1/25/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 36 of 63

Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3

D-0967-2020
Recall number
D-0967-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07232019+52730, Exp 1/19/2020; 07232019+52732, Exp 1/19/2020; 07242019+52748, Exp 1/20/2020; 11212019+53272, Exp 5/19/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 37 of 63

Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0623-1

D-0968-2020
Recall number
D-0968-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 09042019+52874, Exp 3/2/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 38 of 63

Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0624-1

D-0969-2020
Recall number
D-0969-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 09042019+52876, Exp 3/2/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 39 of 63

Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0639-2

D-0970-2020
Recall number
D-0970-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 06102019+52398, Exp 2/24/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 40 of 63

Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1

D-0971-2020
Recall number
D-0971-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 06122019+52423, Exp 7/9/2020; 06122019+52420, Exp 7/9/2020; 07182019+52703, Exp 8/14/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 41 of 63

Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1

D-0972-2020
Recall number
D-0972-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 03202019+51817, Exp 4/16/2020; 09122019+52911, Exp 10/9/2020; 09132019+52918, Exp 8/12/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 42 of 63

MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3

D-0973-2020
Recall number
D-0973-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07102019+52618, Exp 2/8/2020; 09052019+52880, Exp 4/5/2020; 10012019+52983, Exp 5/1/2020; 11052019+53188, Exp 6/5/2020; 12112019+53367, Exp 7/11/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 43 of 63

MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3

D-0974-2020
Recall number
D-0974-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11212019+53263, Exp 2/16/2020; 11252019+53276, Exp 2/20/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 44 of 63

MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3

D-0975-2020
Recall number
D-0975-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 06242019+52513, Exp 1/23/2020; 06242019+52515, Exp 1/23/2020; 07252019+52756, Exp 2/23/2020; 08212019+52823, Exp 3/21/2020; 10012019+52989, Exp 5/1/2020; 11062019+53194, Exp 6/6/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 45 of 63

Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8

D-0976-2020
Recall number
D-0976-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07082019+52606, Exp 4/3/2020; 07242019+52742, Exp 7/22/2020; 07242019+52745, Exp 7/22/2020; 09112019+52907, Exp 5/31/2020; 11142019+53235, Exp 11/12/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 46 of 63

Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1

D-0977-2020
Recall number
D-0977-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 08282019+52850, Exp 1/24/2020; 10102019+53094, Exp 2/28/2020; 10312019+53174, Exp 3/28/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 47 of 63

Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1

D-0978-2020
Recall number
D-0978-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10082019+53069, Exp 2/28/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 48 of 63

Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5

D-0979-2020
Recall number
D-0979-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10012019+52984, Exp 1/19/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 49 of 63

Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3

D-0980-2020
Recall number
D-0980-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 09132019+52914, Exp 2/28/2020; 09162019+52920, Exp 3/2/2020; 09192019+52939; Exp 2/28/2020; 10292019+53162, Exp 4/14/2020; 12112019+53369, Exp 5/27/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 50 of 63

Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3

D-0981-2020
Recall number
D-0981-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11052019+53182, Exp 4/7/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 51 of 63

Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3

D-0982-2020
Recall number
D-0982-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 11042019+53181, Exp 2/2/2020; 12122019+53376, Exp 3/11/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 52 of 63

Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1

D-0983-2020
Recall number
D-0983-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 03252019+51850, Exp 7/6/2020; 04252019+52098, Exp 6/29/2020; 04292019+52108, Exp 6/29/2020; 05012019+52132, Exp 10/22/2020; 05202019+52268, Exp 11/10/2020; 05222019+52290, Exp 11/10/2020; 05302019+52334, Exp 11/20/2020; 07082019+52594, Exp 12/29/2020; 07102019+52619, Exp 12/29/2020; 07292019+52762, Exp 8/12/2020; 07312019+52778, Exp 8/12/2020; 09102019+52898, Exp 1/16/2021; 09112019+52905, Exp 1/18/2021

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 53 of 63

Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2

D-0984-2020
Recall number
D-0984-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 03062019+51706, Exp 6/28/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 54 of 63

Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2

D-0985-2020
Recall number
D-0985-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 03042019+51685, Exp 6/26/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 55 of 63

Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1

D-0986-2020
Recall number
D-0986-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 05292019+52328, Exp 2/13/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 56 of 63

Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2

D-0987-2020
Recall number
D-0987-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 08272019+52841, Exp 2/22/2020; 09242019+52953, Exp 3/22/2020; 11072019+53198, Exp 5/5/2020; 11112019+53206, Exp 5/9/2020; 11122019+53223, Exp 5/10/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 57 of 63

Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1

D-0988-2020
Recall number
D-0988-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 06132019+52446, Exp 7/17/2020; 11142019+53240, Exp 12/18/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 58 of 63

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1

D-0989-2020
Recall number
D-0989-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10102019+53104, Exp 5/4/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 59 of 63

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2

D-0990-2020
Recall number
D-0990-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 08272019+52845, Exp 2/23/2020; 09252019+52965, Exp 3/23/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 60 of 63

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1

D-0991-2020
Recall number
D-0991-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 07162019+52686, Exp 4/11/2020; 11062019+53192, Exp 8/2/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 61 of 63

Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3

D-0992-2020
Recall number
D-0992-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 04082019+51930, Exp 4/8/2020; 09092019+52891, Exp 8/12/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 62 of 63

Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3

D-0993-2020
Recall number
D-0993-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 04292019+52110, Exp 4/28/2020; 06252019+52525, Exp 6/24/2020; 09252019+52962, 10072019+53051, Exp 8/12/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

drug · product 63 of 63

Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3

D-0994-2020
Recall number
D-0994-2020
Initiated
January 15, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 10302019+53170, Exp 2/9/2020

Distribution pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic