Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05)...
FDA Recall #D-150-2013 — Class II — December 7, 2012
Product Description
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Reason for Recall
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Recalling Firm
West-ward Pharmaceutical Corp. — Eatontown, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8,585 bottles
Distribution
Nationwide
Code Information
Lot #: 69364A, 69365A, and 69365B, Exp 10/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated