Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: ...
FDA Recall #D-0878-2023 — Class II — June 16, 2023
Product Description
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Reason for Recall
Packaging defect: blister packaging inadequately sealed.
Recalling Firm
The Harvard Drug Group — La Vergne, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3876 cartons
Distribution
Nationwide in the U.S.
Code Information
Lot #: M04343, Exp. 04/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated