Exact FDA event identifier

Event 90398

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

Event summary

Timeline bucket: June 07, 2022
Product types: Drug
Classifications: Class I and Class II
Statuses: Terminated
Recalling firm wording: Plastikon Healthcare LLC

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

19 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 19

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.

D-1476-2022

Recall number: D-1476-2022
Initiated: June 07, 2022
Classification: Class I
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 24,400 cups

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products

Code information

Lot# 20071A, EXP Jul. 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 19

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.

D-1477-2022

Recall number: D-1477-2022
Initiated: June 07, 2022
Classification: Class I
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 7,700 cups

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products.

Code information

Lot # 20074A, EXP Jul. 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 3 of 19

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

D-1478-2022

Recall number: D-1478-2022
Initiated: June 07, 2022
Classification: Class I
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 220,500 cups

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products.

Code information

Lot# 20076A, EXP Jul. 2022, 20079A, 20081A, EXP Aug. 2022; 21096A, EXP Oct. 2022; 21115A, 21103A, EXP Sep. 2022.

Distribution pattern

Distributed Nationwide in the USA

drug · product 4 of 19

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

D-1479-2022

Recall number: D-1479-2022
Initiated: June 07, 2022
Classification: Class I
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 43,200 cups

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products.

Code information

Lot #: 20051A, EXP Aug. 2022; 20088A, EXP Sep. 2022.

Distribution pattern

Distributed Nationwide in the USA

drug · product 5 of 19

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.

D-1480-2022

Recall number: D-1480-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 502,600 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20072A, 20075A, EXP Jul. 2022; 20087A, EXP Aug. 2022; 20089A, 20090A, EXP Sep. 2022; 20100A, 20102A, EXP Oct. 2022; 20106A, 20107A EXP Nov. 2022; 20109A, EXP Dec. 2022; 21010A, EXP Jan. 2023; 21028A, 21030A, 21032A, EXP Mar. 2023; 21045A, 21046A, EXP Apr. 2023; 21054A, EXP May. 2023; 21078A, 21079A, 21085A, EXP Jul. 2023; 21088A, EXP Aug. 2023

Distribution pattern

Distributed Nationwide in the USA

drug · product 6 of 19

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.

D-1481-2022

Recall number: D-1481-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 92,200 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20085A, EXP Aug. 2022; 20099A, EXP Oct. 2022; 21039A, 21052A, EXP May. 2023; 21114A, EXP Oct. 2023; 21130A, 21132A, EXP Dec. 2023.

Distribution pattern

Distributed Nationwide in the USA

drug · product 7 of 19

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

D-1482-2022

Recall number: D-1482-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 521,700 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20077A, 20080A, 20082A, EXP Aug. 2022; 21016A, EXP Feb. 2023; 21026A, EXP Mar. 2023; 21042A, 21047A, 21050A, EXP Apr. 2023; 21057A, 21059A, 21060A,EXP May. 2023; 21061A, 21067A, 21070A, 21072A, EXP Jun. 2023; 21095A, 21097A, 21099A, EXP Sep. 2023; 21107A, 21109A, 21111A, 21113A, EXP Oct. 2023; 21138A, EXP Dec. 2023; 22002A, 22004A, 22005A, EXP Jan. 2024

Distribution pattern

Distributed Nationwide in the USA

drug · product 8 of 19

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

D-1483-2022

Recall number: D-1483-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 88,500 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20084A, 20086A, EXP Aug. 2022; 21074A, 21077A, EXP Jul. 2023

Distribution pattern

Distributed Nationwide in the USA

drug · product 9 of 19

Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70

D-1484-2022

Recall number: D-1484-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 290,270 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot# 20078A, 20083A EXP Aug. 2022; 20092A, EXP Sep. 2022; 21058A, 21048C, EXP May. 2023; 21063C, EXP Jun. 2023; 21093B, EXP Sep. 2023; 22001C, EXP Jan. 2024; 22017A, EXP Mar. 2024.

Distribution pattern

Distributed Nationwide in the USA

drug · product 10 of 19

Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71

D-1485-2022

Recall number: D-1485-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 848,500 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20062A, 20067A, EXP Jun. 2022; 20092A, 20093A, EXP Sep. 2022; 20101A, 21110A, EXP Oct. 2022; 20108A, EXP Nov. 2022; 21012A, EXP Jan. 2023; 21044A, 21048B, EXP Apr. 2023; 21053A, EXP May. 2023; 21063B, 21068B, EXP Jun. 2023; 21084B, EXP Jul. 2023; 21090A, EXP Aug. 2023; 21119A, EXP Nov. 2023; 21122B, EXP Dec. 2023; 22001B, 22006A, EXP Jan. 2024; 22017B, EXP Mar. 2024

Distribution pattern

Distributed Nationwide in the USA

drug · product 11 of 19

Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76

D-1486-2022

Recall number: D-1486-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 3,507,740 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20064A, 20066A, EXP Jun. 2022; 20069A, 20073A, EXP Jul. 2022; 20094A, 20094B, 20095A, 20095B, EXP Sep. 2022; 20103A, EXP Oct. 2022; 20105A, EXP Nov. 2022; 20111A, 20111B, EXP Dec. 2022; 21005A, 21005B, EXP Jan. 2023; 21019A, 21019B, EXP Feb. 2023; 21035A, 21035B, 21038A, EXP Mar. 2023; 21048A, 21048D, EXP Apr. 2023; 21058B, EXP May. 2023; 21063A, 21068A, EXP Jun. 2023; 21084A, EXP Jul. 2023; 21090B, EXP Aug. 2023; 21093A, EXP Sep. 2023; 21124A, 21126A, EXP Nov. 2023; 21136A,20112A, 21122A,21122C, 20112B, EXP Dec. 2023; 22001A, 22001D, 22006B, 22006C, EXP Jan. 2024; 22010A, 22011A, 22011B, EXP Feb. 2024; 22014A, 22015A, 22021A, EXP Mar. 2024.

Distribution pattern

Distributed Nationwide in the USA

drug · product 12 of 19

CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94

D-1487-2022

Recall number: D-1487-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 49,280 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 21021A, 21023A, 21024A, EXP Feb. 2023; 21064A, EXP Jun. 2023; 21073A, 21075A, EXP Jul. 2023; 21100A, EXP Sep. 2023; 21118A, 21120A, EXP Nov. 2023; 21128A, 21129A, 21131A, 21135A, EXP Dec. 2023; 22019A, EXP Mar. 2024.

Distribution pattern

Distributed Nationwide in the USA

drug · product 13 of 19

Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70

D-1488-2022

Recall number: D-1488-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 217,700 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20063A, EXP Jun. 2022; 20098A, EXP Oct. 2022; 21055B, EXP May. 2023; 21066A, EXP Jun. 2023; 21083B, EXP Jul. 2023; 21112B, EXP Oct. 2023; 22009A, EXP Feb. 2024.

Distribution pattern

Distributed Nationwide in the USA

drug · product 14 of 19

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72

D-1489-2022

Recall number: D-1489-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 349,100 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20065A, EXP Jun. 2022; 20068A, 20070A, EXP Jul. 2022; 20097A, 20098A, EXP Oct. 2022; 21055A, EXP May. 2023; 21083A, EXP Jul. 2023; 21091A, EXP Aug. 2023; 21112A, EXP Oct. 2023

Distribution pattern

Distributed Nationwide in the USA

drug · product 15 of 19

GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70

D-1490-2022

Recall number: D-1490-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 280,500 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21013A, EXP Feb. 2023; 21041A, EXP Apr. 2023; 21102A, EXP Sep. 2023; 21121A, 21127A, EXP Nov. 2023; 22003A, 22007A, EXP Jan. 2024; 22016A, EXP Mar. 2024

Distribution pattern

Distributed Nationwide in the USA

drug · product 16 of 19

GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72

D-1491-2022

Recall number: D-1491-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 246,200 cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21017A, EXP Feb. 2023; 21034A, 21036A EXP Mar. 2023; 21092A, EXP Aug. 2023; 21105A, 21106A, EXP Oct. 2023; 21134A, EXP Dec. 2023; 22007B, EXP Jan. 2024; 22012A, EXP Feb. 2024; 22016B, EXP Mar. 2024

Distribution pattern

Distributed Nationwide in the USA

drug · product 17 of 19

CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3

D-1492-2022

Recall number: D-1492-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 7,200 ampoules

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 21011A, EXP Jan. 2023

Distribution pattern

Distributed Nationwide in the USA

drug · product 18 of 19

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

D-1493-2022

Recall number: D-1493-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 1,464 ampoules

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 20096A, EXP Oct. 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 19 of 19

CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7

D-1494-2022

Recall number: D-1494-2022
Initiated: June 07, 2022
Classification: Class II
Status: Terminated
Recalling firm: Plastikon Healthcare LLC
Quantity: 1,464 ampoules

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information

Lot # 21014A, EXP Feb. 2023

Distribution pattern

Distributed Nationwide in the USA