Losartan Potassium 100 mg Tablets # 30 Losartan recall: Impurity Out of Spec
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed…
Why was Losartan Potassium 100 mg Tablets # 30 Losartan recalled?
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
- Product
- Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed…
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Quantity
- 300 tablets
- Distribution
- Product was distributed to a physician's office in California.
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)