Why it was recalled
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0078-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 18, 2021
- FDA report date
- Nov 3, 2021
- Quantity
- 135,082 Blister Packs/2,431,476 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MACLEODS PHARMA USA, INC
Original FDA data
Every field from FDA enforcement report D-0078-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88872
- Address
- 103 College Rd E Fl 2
- Code information
- Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
- Postal code
- 08540-6611
- Report date
- Nov 3, 2021
- Product type
- Drugs
- Recall number
- D-0078-2022
- Classification
- Class III
- Recalling firm
- MACLEODS PHARMA USA, INC
- Product quantity
- 135,082 Blister Packs/2,431,476 tablets
- Termination date
- Apr 24, 2024
- Reason for recall
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 18, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2021