Class II · Moderate risk Ongoing
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC…
Reason Out of Specification for Dissolution
Irbesartan Bulk Active Pharmaceutical Ingredient.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
What was recalled
Irbesartan Bulk Active Pharmaceutical Ingredient.
- Recalling firm
- Aurobindo Pharma Limited (Unit I)
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0127-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Irbesartan recalls
See all
Class II · Moderate risk Terminated
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India…
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09)…
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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