FDAFDA · Food and drugs·Recall number D-0878-2023
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
Published July 5, 2023 · Recall initiated: June 16, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging defect: blister packaging inadequately sealed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #: M04343, Exp. 04/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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