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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89356

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

Open FDA event record

Event summary

Timeline bucket
December 06, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medique Products

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

3 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 3

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6

D-0389-2022
Recall number
D-0389-2022
Initiated
December 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medique Products
Quantity
3,260,400 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Code information

Lots: (Packet, Carton) 6151, 4360 Exp. 10/2021; 6240, 4446 Exp. 12/2021; 6331, 4484 Exp. 02/2022; 6413, 4551 Exp. 04/2022; 6699, 4679 Exp. 10/2022; 6751, 4714 Exp. 12/2022; 6855, 4750 Exp. 01/2023; 6868, 4761 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 7061, 4821 Exp. 05/2023.

Distribution pattern

Nationwide in the USA

drug · product 2 of 3

Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.

D-0390-2022
Recall number
D-0390-2022
Initiated
December 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medique Products
Quantity
16,630,118 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Code information

Lots: (packet lot, carton lot) a) 7062, 10611 Exp. 05/2023; 7062, 10110 Exp. 05/2023; 7062, 10067 Exp. 05/2023; 6414, 07378 Exp. 04/2022; 6700, 08047 Exp. 10/2022; 6152, 05553 Exp. 10/2022; 6239, 07120 Exp. 12/2021; 6239, 06504 Exp. 12/2021; 6152, 05737 Exp. 10/2021; 6700, 08653 Exp. 10/2022; 6330, 07217 Exp. 02/2022; 6414, 07360 Exp. 04/2022; 6749, 08717 Exp. 12/2022; 6794, 09012 Exp. 12/2022; b) 6856, 09108 Exp. 01/2023; 6867, 09460 Exp. 02/2023; 6900, 10105 Exp. 02/2023; 6749, 09139 Exp. 12/2022; 6152, 05944 Exp. 10/2021; 6152, 05483 Exp. 10/2021; 6414, 07488 Exp. 04/2022; 6493, 07662 Exp. 06/2022; 6414, 07286 Exp. 04/2022; 6493, 07709 Exp. 06/2022; 6414, 07524 Exp. 04/2022; 6330, 06728 Exp. 02/2022; 6330, 06366 Exp. 02/2022; 6239, 06503 Exp. 12/2021; 6330, 06460 Exp. 02/2022; c) 7070, 10605 Exp. 06/2023; 7063, 11089 Exp. 06/2023; 7070, 11020 Exp. 06/2023; 6867, 09545 Exp. 02/2023; 7062, 10066 Exp. 05/2023; 6749, 08650 Exp. 12/2022; 6493, 07784 Exp. 06/2022; 6493, 07920 Exp. 06/2022; 6330, 06949 Exp. 02/2022; 6239, 06945 Exp. 12/2021; 6239, 05973 Exp. 12/2021; 6152, 05687 Exp. 10/2021; 6493, 07950 Exp. 06/2022; 6493, 07825 Exp. 06/2022; d) 7062, 10265 Exp. 05/2023; 7070, 10980 Exp. 06/2023; 6867, 09607 Exp. 02/2023; 6152, 06039 Exp. 10/2021; 6330, 07121 Exp. 02/2022; 6700, 08040 Exp. 10/2022; 6493, 07985 Exp. 06/2022; 6152, 05783 Exp. 10/2021; 6749, 08866 Exp. 12/2022.

Distribution pattern

Nationwide in the USA

drug · product 3 of 3

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

D-0391-2022
Recall number
D-0391-2022
Initiated
December 06, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medique Products
Quantity
6,639,838 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Code information

Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023

Distribution pattern

Nationwide in the USA