The Recall Desk
ModerateFDA (Drugs)·D-204-2013·Announced 2013-03-27

Watson Recalls Meprobamate Tablets Due to Impurity Failure

Watson Laboratories is recalling meprobamate 400 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, a Class II recall without reported adverse health consequences is typically scored as Moderate (2) or High (3); given the lack of reported harm and the specific nature of the impurity failure, Moderate is appropriate.

Plain-English summary

Watson Laboratories Inc. is recalling Meprobamate Tablets USP, 400 mg, 100 tablets (NDC 0591-5238-01). The recall involves 20,587 bottles distributed nationwide and in Puerto Rico.

The recall was initiated because the product failed impurity/degradation specifications. Specifically, an out-of-specification result was found for the impurity diphenyl sulfone.

Affected lots include 387879A (Exp. 02/13), 429105A (Exp. 06/13), 474488A (Exp. 11/13), 491672A (Exp. 01/14), and 529095A (Exp. 04/14). Consumers should check their medication for these lot numbers and expiration dates. If the medication matches the recalled lots, they should stop using it and consult their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
Manufacturer
Watson Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
20,587

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 (10)

  • 387879A
  • Exp. 02/13
  • 429105A
  • Exp. 06/13
  • 474488A
  • Exp. 11/13
  • 491672A
  • Exp. 01/14
  • 529095A
  • Exp. 04/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Watson Laboratories Inc 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 2 products in this recall →

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Same hazard · impurity

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