PlainRecordsFDA · Drug recall
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg…
- Date
- Sept. 18, 2019
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- AVKARE Inc.
- Product
- AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
- Reason
- Failed Stability Specifications.
- Distribution pattern
- Nationwide in the U.S.
- Quantity
- 5953 bottles
- Codes and lots
- Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021
- Recall started
- Aug. 28, 2019
- Recall number
- D-1875-2019
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-1875-2019. The agency record governs; check it and the company before acting.