Home / Recalls / Camber Pharmaceuticals Inc / D-1041-2019

D-1041-2019 Class II Ongoing

Recalled by Camber Pharmaceuticals Inc — Piscataway, NJ

Recall Details

Product Type
Drugs
Report Date
March 27, 2019
Initiation Date
February 28, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
351,732 bottles

Product Description

Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

Reason for Recall

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Distribution Pattern

Nationwide

Code Information

a) LOP17026B, LOP17050, LOP1705, LOP17052, LOP17053, Exp. Sep-19; LOP17061, Exp. Oct-19; LOP18035, LOP18036, Exp. Dec-19; b) LOP17026, Exp. Sep-19; c) LOP17006, Exp. May-19, LOP17025, Exp. Sep-19, LOP17068, Exp, Oct-19, LOP18037, LOP18038, LOP18039, Exp. Dec-19, LOP18057, Exp. Jan-20

Other recalls by Camber Pharmaceuticals Inc

  • D-0567-2023 Class I — Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufact (March 13, 2023)
  • D-0094-2023 Class III — Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, (December 6, 2022)
  • D-1043-2019 Class II — Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), (February 28, 2019)
  • D-1042-2019 Class II — Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), (February 28, 2019)