The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-203-2013·Announced 2013-03-27

Watson Recalls Meprobamate Tablets Due to Impurity Specification Failure

Watson Laboratories is recalling meprobamate 200 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when specific impurity failures are involved.

Plain-English summary

Watson Laboratories Inc. is recalling Meprobamate, Tablets USP, 200 mg, 100 tablets (NDC 9591-5239-01). The recall involves 9,824 bottles distributed nationwide and in Puerto Rico. Affected lot codes include 386585A, 429104A, 474487A, and 491671A, with expiration dates ranging from 02/13 to 01/14.

The recall was initiated because an out-of-specification result was found for the impurity diphenyl sulfone. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific NDC and lot codes listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit.

The recalled product

Product
Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01
Manufacturer
Watson Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
9,824

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 (8)

  • 386585A
  • Exp. 02/13
  • 429104A
  • Exp. 06/13
  • 474487A
  • Exp. 11/13
  • 491671A
  • Exp.01/14.

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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