Home / Recalls / Aurobindo Pharma USA Inc. / D-1088-2023

D-1088-2023 Class II Terminated

Recalled by Aurobindo Pharma USA Inc. — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
August 30, 2023
Initiation Date
July 21, 2023
Termination Date
February 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48 bottles

Product Description

Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08

Reason for Recall

cGMP deviations: Batch was released prior to approval.

Distribution Pattern

USA nationwide

Code Information

Lot #: RB4023002A, Exp 02/2025

Other recalls by Aurobindo Pharma USA Inc.

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  • D-0149-2025 Class II — Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo (December 6, 2024)
  • D-0079-2025 Class II — Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-3 (November 7, 2024)
  • D-0078-2025 Class II — Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30 (November 7, 2024)
  • D-0077-2025 Class II — Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-3 (November 7, 2024)
  • D-0641-2024 Class I — Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/ (July 11, 2024)
  • D-0491-2024 Class II — Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13 (April 24, 2024)
  • D-0492-2024 Class II — Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 131 (April 24, 2024)
  • D-1171-2023 Class II — Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. M (August 2, 2023)
  • D-1087-2023 Class II — Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distribut (July 21, 2023)