Recalls / Class II
Class IID-0905-2023
Product
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
- Brand name
- Kirkland Signature Aller Fex
- Generic name
- Fexofenadine Hydrochloride
- Active ingredient
- Fexofenadine Hydrochloride
- Route
- Oral
- NDC
- 63981-847
- FDA application
- ANDA212971
- Affected lot / code info
- Lot #: 2DV1487, 2DV1870, 2DV1871, 2DV1873, 2EV1676, 2GV2132, 2HV2679, Exp. date 12/23; 2DV2000, exp. date 11/23; 2LV1573, 2MV1314, Exp. date 04/24; 2FV1764, 2FV1765 2FV1766, 2GV1579, 2GV1937, 2GV1941 , 2GV1942, 2GV2157, 2HV1886, 2HV1997, 2HV2019, 2HV2047, Exp. datev02/24; 2EV1666, 2EV1667, 2EV1668, 2EV1670, 2EV1671, 2EV1672, 2EV1674, 2EV1677, 2EV1678, 2HV2017, Exp. date 01/24.
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- L. Perrigo Company
- Manufacturer
- Costco Wholesale Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 360,184
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2023-02-09
- FDA classified
- 2023-07-11
- Posted by FDA
- 2023-07-19
- Terminated
- 2023-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0905-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.