Recalls / Class II
Class IID-0901-2023
Product
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47
- Brand name
- Berkley Jensen Allergy Relief
- Generic name
- Fexofenadine Hydrochloride
- Active ingredient
- Fexofenadine Hydrochloride
- Route
- Oral
- NDC
- 68391-847
- FDA application
- ANDA212971
- Affected lot / code info
- Lot #:2DV1863, 2HV2698, Exp. date 12/23; 2GV1583, Exp. date 02/24; 2GV1950, 2HV2697, Exp. Date 01/24.
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- L. Perrigo Company
- Manufacturer
- BJWC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 23,868 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-0901-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.