Recalls / Class II
Class IID-0909-2023
Product
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
- Brand name
- Allergy Relief
- Generic name
- Fexofenadine Hydrochloride
- Active ingredient
- Fexofenadine Hydrochloride
- Route
- Oral
- NDC
- 56062-847
- FDA application
- ANDA212971
- Affected lot / code info
- Lot #: a) 2CR0652, 2DR0464, 2DR0465,Exp. Date 12/23; 2ER0285, Exp. Date 01/24. b) 2DR0466, Exp. Date 12/23; 2ER0412, Exp. Date 01/24; 2GR0330, Exp. Date 04/24
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- L. Perrigo Company
- Manufacturer
- Publix Super Markets Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 32,904 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-0909-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.