Home / Recalls / Lupin Pharmaceuticals Inc. / D-0648-2024

D-0648-2024 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
September 4, 2024
Initiation Date
August 21, 2024
Termination Date
April 29, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4554 bottles

Product Description

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Reason for Recall

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Distribution Pattern

USA nationwide.

Code Information

Lot #: F201517, Exp 11/30/2024

Other recalls by Lupin Pharmaceuticals Inc.

  • D-0220-2026 Class II — Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syring (November 13, 2025)
  • D-0227-2026 Class II — Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manuf (November 5, 2025)
  • D-0542-2025 Class II — Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx (July 2, 2025)
  • D-0537-2025 Class II — clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican B (June 27, 2025)
  • D-0532-2025 Class II — Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, R (June 20, 2025)
  • D-0377-2025 Class II — clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manuf (April 10, 2025)
  • D-0167-2025 Class II — Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Ma (December 20, 2024)
  • D-0053-2025 Class II — Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 681 (October 23, 2024)
  • D-0054-2025 Class II — Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68 (October 23, 2024)
  • D-0052-2025 Class II — Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 6 (October 23, 2024)