Recalls / Class II
Class IID-0878-2023
Product
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
- Affected lot / code info
- Lot #: M04343, Exp. 04/2024
Why it was recalled
Packaging defect: blister packaging inadequately sealed.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 3876 cartons
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2023-06-16
- FDA classified
- 2023-06-26
- Posted by FDA
- 2023-07-05
- Terminated
- 2024-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0878-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.