Recalls / Class III
Class IIID-0079-2022
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
- Brand name
- Rizatriptan Benzoate
- Generic name
- Rizatriptan Benzoate
- Active ingredient
- Rizatriptan Benzoate
- Route
- Oral
- NDCs
- 33342-093, 33342-094
- FDA application
- ANDA203146
- Affected lot / code info
- Lot #: BRL2102A, BRL2103A, exp. date 04/2025
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
- 13,260 Blister Packs/238,680 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-0079-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.