Drug product
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
D-0079-2022
Product summary
- Event
- Event 88872
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,260 Blister Packs/238,680 tablets
- Official record key
drug-enforcement:D-0079-2022
Official wording
Reason: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Code information: Lot #: BRL2102A, BRL2103A, exp. date 04/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out-of-specification