FDA Drug Recalls

Recalls / Class II

Class IID-0911-2023

Product

Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03

Affected lot / code info
Lot#: 2DR0471, Exp. Date 12/23

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
6,216 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-0911-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.