Recalls / Class III
Class IIID-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
- Brand name
- Rizatriptan
- Generic name
- Rizatriptan
- Active ingredient
- Rizatriptan Benzoate
- Route
- Oral
- NDCs
- 33342-087, 33342-088
- FDA application
- ANDA203147
- Affected lot / code info
- Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
Why it was recalled
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Recalling firm
- Firm
- MACLEODS PHARMA USA, INC
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 103 College Rd E Fl 2, N/A, Princeton, New Jersey 08540-6611
Distribution
- Quantity
- 135,082 Blister Packs/2,431,476 tablets
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-18
- FDA classified
- 2021-10-28
- Posted by FDA
- 2021-11-03
- Terminated
- 2024-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0078-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.