MACLEODS PHARMA USA, INC: Drug Recall

Recall #D-0080-2022 · 10/18/2021

Class III: Low Risk

Recall Details

Recall Number: D-0080-2022
Classification: Class III
Product Type: Drug
Recalling Firm: MACLEODS PHARMA USA, INC
Status: Terminated
Date Initiated: 10/18/2021
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 643,800 Blister Packs /888,336 Tablets

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Other Recalls by MACLEODS PHARMA USA, INC

Class II: Risk 05/07/2024

Presence of foreign substance: plastic-like substance.
Class III: Low Risk 01/05/2023

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II: Risk 06/16/2022

Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II: Risk 06/10/2022

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 04/15/2022

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

View all recalls by MACLEODS PHARMA USA, INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.