Drug product
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
D-0078-2022
Product summary
- Event
- Event 88872
- Status
- Terminated
- Classification
- Class III
- Quantity
- 135,082 Blister Packs/2,431,476 tablets
- Official record key
drug-enforcement:D-0078-2022
Official wording
Reason: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Code information: Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out-of-specification