Recall Enforment Report D-0079-2022

Multi event Drug Recall Enforcement Report Class III voluntary initiated by MACLEODS PHARMA USA, INC, originally initiated on 10-18-2021 for the product Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 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 33342-093-41 The product was recalled due to out-of-specification test results obtained in organic impurities test during analysis of controlled samples.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0079-202210-18-202111-03-2021Class III13,260 Blister Packs/238,680 tabletsRizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 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 33342-093-41Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.Ongoing
D-0080-202210-18-202111-03-2021Class III643,800 Blister Packs /888,336 TabletsRizatriptan 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 33342-094-41Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.Ongoing
D-0078-202210-18-202111-03-2021Class III135,082 Blister Packs/2,431,476 tabletsRizatriptan 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, INDIAOut-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
33342-087Rizatriptan RizatriptanTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-088Rizatriptan RizatriptanTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-093Rizatriptan Benzoate Rizatriptan BenzoateTablet, Orally DisintegratingOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-094Rizatriptan Benzoate Rizatriptan BenzoateTablet, Orally DisintegratingOralMacleods Pharmaceuticals LimitedHuman Prescription Drug