FDA Drug recall D-0567-2023
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 0885…
- FDA Drug
- Class I
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class I recall of Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 0885… by Camber Pharmaceuticals, citing microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0567-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-03-13 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Camber Pharmaceuticals |
| Distribution | US |
Product
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
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Identifiers
| ndc | 31722-629-21 |
|---|---|
| code_info | Lot# E220182, Exp. 12/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Camber Pharmaceuticals
- Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,…
FDA Drug · Class III · 2022-12-21 · Camber Pharmaceuticals - Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-7…
FDA Drug · Class II · 2019-03-27 · Camber Pharmaceuticals - 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 3172…
FDA Drug · Class II · 2019-03-27 · Camber Pharmaceuticals - Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-70…
FDA Drug · Class II · 2019-03-27 · Camber Pharmaceuticals
All Camber Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0567-2023%22
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