D-0080-2022 Class III Terminated
FDA drug recall D-0080-2022 was initiated by MACLEODS PHARMA USA, INC on October 18, 2021 and is designated Class III. Reason for recall: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. The recall status is terminated (terminated April 24, 2024). Affected quantity: 643,800 Blister Packs /888,336 Tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- November 3, 2021
- Initiation Date
- October 18, 2021
- Termination Date
- April 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 643,800 Blister Packs /888,336 Tablets
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
Reason for Recall
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025