Home / Recalls / Camber Pharmaceuticals Inc. / D-0567-2023

D-0567-2023 Class I Ongoing

Recalled by Camber Pharmaceuticals Inc. — Piscataway, NJ

Recall Details

Product Type
Drugs
Report Date
May 17, 2023
Initiation Date
March 13, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1568 bottles

Product Description

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.

Reason for Recall

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Distribution Pattern

Nationwide in the USA

Code Information

Lot# E220182, Exp. 12/31/2023

Other recalls by Camber Pharmaceuticals Inc.

  • D-0094-2023 Class III — Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, (December 6, 2022)
  • D-1041-2019 Class II — Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), (February 28, 2019)
  • 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)