Class II
Terminated
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
This recall has been terminated (originally issued July 5, 2023).
- Company
- The Harvard Drug Group
- Recall Initiated
- June 16, 2023
- Posted
- July 5, 2023
- Recall Number
- D-0878-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3876 cartons
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Packaging defect: blister packaging inadequately sealed.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: M04343, Exp. 04/2024
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