Why it was recalled
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
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-0080-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 18, 2021
- FDA report date
- Nov 3, 2021
- Quantity
- 643,800 Blister Packs /888,336 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MACLEODS PHARMA USA, INC
Original FDA data
Every field from FDA enforcement report D-0080-2022, 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 #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
- Postal code
- 08540-6611
- Report date
- Nov 3, 2021
- Product type
- Drugs
- Recall number
- D-0080-2022
- Classification
- Class III
- Recalling firm
- MACLEODS PHARMA USA, INC
- Product quantity
- 643,800 Blister Packs /888,336 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 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 18, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2021