MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma
Recalled November 3, 2021 · FDA recall D-0080-2022 · MACLEODS PHARMA USA
Hazard
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. · FDA Class III
Units
643,800 Blister Packs /888,336 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 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
Manufacturer(s)
MACLEODS PHARMA USA, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →