Drug recall D-0080-2022
Product
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 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 33342-094-41
Reason for recall
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Lots and codes
Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
Recall details
- Recalling firm
- MACLEODS PHARMA USA, INC, Princeton, NJ
- Quantity
- 643,800 Blister Packs /888,336 Tablets
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 18, 2021
- Terminated
- April 24, 2024
Related products
- Rizatriptan Benzoate – drug information
- NDC 33342-094 Rizatriptan benzoate · Rizatriptan Benzoate 10 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-093 Rizatriptan benzoate · Rizatriptan Benzoate 5 mg/1 · Macleods Pharmaceuticals Limited