MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33
Recalled November 3, 2021 · FDA recall D-0078-2022 · MACLEODS PHARMA USA
Hazard
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. · FDA Class III
Units
135,082 Blister Packs/2,431,476 tablets
Sold at
Nationwide within the United States
Description
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
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
Manufacturer(s)
MACLEODS PHARMA USA, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →