Drug Enforcement D-0905-2023

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class II

Report Date

July 19, 2023

Termination Date

September 11, 2023

Product Information

Product description
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
Product quantity
360,184
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-0905-2023
Event ID
91672
Recall initiation date
February 9, 2023
Center classification date
July 11, 2023
Code info
Lot #: 2DV1487, 2DV1870, 2DV1871, 2DV1873, 2EV1676, 2GV2132, 2HV2679, Exp. date 12/23; 2DV2000, exp. date 11/23; 2LV1573, 2MV1314, Exp. date 04/24; 2FV1764, 2FV1765 2FV1766, 2GV1579, 2GV1937, 2GV1941 , 2GV1942, 2GV2157, 2HV1886, 2HV1997, 2HV2019, 2HV2047, Exp. datev02/24; 2EV1666, 2EV1667, 2EV1668, 2EV1670, 2EV1671, 2EV1672, 2EV1674, 2EV1677, 2EV1678, 2HV2017, Exp. date 01/24.
More code info
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