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
Reported: July 5, 2023 Initiated: June 16, 2023 #D-0878-2023
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.
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 3876 cartons
- Distribution
- Nationwide in the U.S.
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group. Units affected: 3876 cartons.
Why was this product recalled? ▼
Packaging defect: blister packaging inadequately sealed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 5, 2023. Severity: Moderate. Recall number: D-0878-2023.
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