Status
Terminated
Drug Enforcement D-0908-2023
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
July 19, 2023
Termination Date
September 11, 2023
Product Information
- Product description
- 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.
- Product quantity
- 32,376 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the USA
Location & Firm
- Recalling firm
- L. Perrigo Company
- Address
-
515 Eastern Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0908-2023
- Event ID
- 91672
- Recall initiation date
- February 9, 2023
- Center classification date
- July 11, 2023
- 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
- More code info
- —