The Recall Desk
ModerateFDA (Drugs)·D-0390-2022·Announced 2022-01-26

Medique Pain-Off Tablets Recalled for Manufacturing Practice Violations

Medique Products is recalling Medique Pain-Off tablets nationwide after an FDA inspection found the products were not manufactured under Current Good Manufacturing Practices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation without documented harm; therefore, it falls under the Moderate category per the rubric criterion for low-risk issues or voluntary precautionary recalls.

Plain-English summary

Medique Products is recalling Medique Pain-Off tablets, which contain Acetaminophen 250 mg, Aspirin (NSAID) 250 mg, and Caffeine 65 mg. The recall affects multiple package sizes distributed nationwide in the USA.

The recall was initiated after an FDA inspection determined that these products were not manufactured under Current Good Manufacturing Practices (CGMP), which are required quality and safety standards for drug manufacturing.

Consumers who have purchased affected lots should stop using the product. Consumers with questions or concerns should contact Medique Products for further guidance.

The recalled product

Product
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
Manufacturer
Medique Products
Category
Drug — Over-the-Counter Pain Reliever
Hazard
Affected units
16,630,118

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lots: (packet lot
  • carton lot) a) 7062
  • 10611 Exp. 05/2023
  • 7062
  • 10110 Exp. 05/2023
  • 10067 Exp. 05/2023
  • 6414
  • 07378 Exp. 04/2022
  • 6700
  • 08047 Exp. 10/2022
  • 6152
  • 05553 Exp. 10/2022
  • 6239
  • 07120 Exp. 12/2021
  • 06504 Exp. 12/2021
  • 05737 Exp. 10/2021
  • 08653 Exp. 10/2022
  • 6330
  • 07217 Exp. 02/2022
  • 07360 Exp. 04/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Medique Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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