The Recall Desk
SevereFDA (Drugs)·D-397-2014·Announced 2014-01-15

Watson Recalls Carisoprodol Tablets Due to Metal Particulates

Watson Laboratories is recalling 4,439 bottles of Carisoprodol Tablets because metal particulates were visually observed in the tablets.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving physical contamination like metal particulates which poses a risk of injury.

Plain-English summary

Watson Laboratories Inc is recalling 4,439 bottles of Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. The product is manufactured by Watson Pharma Private Ltd in India and distributed by Watson Pharma Ltd in Parsippany, NJ. The specific lot affected is # 244152A with an expiration date of 01/15.

The recall was initiated due to the presence of a foreign substance, specifically metal particulates that were visually observed in the tablets. The agency has classified this recall as Class II.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement.

The recalled product

Product
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
Affected units
4,439

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 (2)

  • Lot # 244152A
  • exp 01/15.

Distribution

Distributed nationwide across the United States.