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
Reported: March 27, 2019 Initiated: February 28, 2019 #D-1041-2019
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
Details
- Recalling Firm
- Camber Pharmaceuticals Inc
- Units Affected
- 351,732 bottles
- Distribution
- Nationwide
- Location
- Piscataway, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Camber Pharmaceuticals Inc. Units affected: 351,732 bottles.
Why was this product recalled? ▼
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1041-2019.
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