Camber Pharmaceuticals Recalls Losartan Potassium Tablets Due to NMBA Contamination
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the impurity NMBA were detected in the active ingredient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
Camber Pharmaceuticals Inc is recalling Losartan Potassium Tablets USP, 50 mg, in 30, 90, and 1000-count bottles. The recall involves 69,712 bottles distributed nationwide. The product is manufactured by Hetero Hetero Labs Limited in India.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) in the active pharmaceutical ingredient. The agency has classified this recall as Class II.
Consumers with these specific bottles should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatments. Specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Camber Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 69,712
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) LOP17028C
- Exp. Sep-19
- LOP17064A
- Exp. Nov-19
- b) LOP17027
- Exp Sep-19
- LOP17063
- LOP17093
- LOP17094
- LOP17095
- LOP17097A
- LOP17105
- LOP17107
- Exp. Dec-19
- c) LOP17004
- Exp Dec-19
- LOP17028B
- LOP17048
- LOP17049 Exp Oct-19
- LOP17056
UPCs (3)
- 0331722702300
- 0331722700900
- 0331722701303
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Camber Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · LOSARTAN POTASSIUM
- HighLosartan Potassium Tablets Recalled for Blue Plastic Contamination
FDA (Drugs) · 2023-07-12
- HighLosartan Potassium tablets recalled for elevated AZIDO impurity
FDA (Drugs) · 2022-07-06
- HighLosartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels
FDA (Drugs) · 2022-07-06
- HighLosartan Potassium Tablets Recalled for Manufacturing Impurity Issues
FDA (Drugs) · 2022-07-06
- ModerateLosartan Potassium tablets recalled for excessive AZIDO impurity
FDA (Drugs) · 2022-06-08
Same manufacturer · Camber Pharmaceuticals Inc
See all →- SevereAtovaquone Oral Suspension Recalled for Bacillus cereus Contamination
FDA (Drugs) · 2023-05-17
- ModerateLacosamide oral solution recalled for failed excipient specifications
FDA (Drugs) · 2022-12-21
- SevereCamber Pharmaceuticals Recalls Losartan Potassium Tablets Due to NMBA Contamination
FDA (Drugs) · 2019-03-27
- SevereCamber Pharmaceuticals Recalls Losartan Potassium Tablets Due to NMBA Contamination
FDA (Drugs) · 2019-03-27