Drug recall D-0078-2022
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
Reason for recall
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Lots and codes
Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
Recall details
- Recalling firm
- MACLEODS PHARMA USA, INC, Princeton, NJ
- Quantity
- 135,082 Blister Packs/2,431,476 tablets
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 18, 2021
- Terminated
- April 24, 2024
Related products
- Rizatriptan – drug information
- NDC 33342-087 Rizatriptan · Rizatriptan Benzoate 5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-088 Rizatriptan · Rizatriptan Benzoate 10 mg/1 · Macleods Pharmaceuticals Limited