Recalls / Class II
Class IID-0904-2023
Product
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39
- Brand name
- Exchange Select Aller Ease
- Generic name
- Fexofenadine Hydrochloride
- Active ingredient
- Fexofenadine Hydrochloride
- Route
- Oral
- NDC
- 55301-847
- FDA application
- ANDA212971
- Affected lot / code info
- Lot #: 2ER0285,Exp. date 01/24
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- L. Perrigo Company
- Manufacturer
- Army & Air Force Exchange Service
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 1,920 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-0904-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.