Drug product
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
D-0305-2026
Product summary
- Event
- Event 98345
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 71424 bottles.
- Official record key
drug-enforcement:D-0305-2026
Official wording
Reason: Presence of Foreign Tablets/Capsules
Code information: Batch # 6160008A, Exp Date: 12/31/2026
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets