Class II
Terminated
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816
This recall has been terminated (originally issued April 15, 2020).
- Company
- Avet Pharmaceuticals, Inc.
- Recall Initiated
- March 26, 2020
- Posted
- April 15, 2020
- Recall Number
- D-1104-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 12,168; b) 17,196; c) 3,890
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Distribution
Nationwide
Lot / Code Info
a) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp Mar 2020; CL018013A, CL018015A, CL018016A, CL018017A, exp Apr 2020
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