Recalls / Class II
Class IID-0908-2023
Product
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
- Brand name
- Good Sense Aller Ease
- Generic name
- Fexofenadine Hydrochloride
- Active ingredient
- Fexofenadine Hydrochloride
- Route
- Oral
- NDC
- 0113-0847
- FDA application
- ANDA212971
- Affected lot / code info
- Lot #: a) 2DV1869, 2EV1613, 2EV1614, Exp. date 12/23; 2EV1820, 2FV1943, Exp. date 01/24; 2GV1893, Exp. date 04/24. Lot #: b) 2CR0653, 2DR0466, Exp. date 12/23, 2ER2087, Exp. date 01/24
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- L. Perrigo Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 32,376 cartons
- 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-0908-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.