D-0128-2018 Class II Terminated

Recalled by L. Perrigo Company — Allegan, MI

FDA drug recall D-0128-2018 was initiated by L. Perrigo Company on November 8, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products The recall status is terminated (terminated December 13, 2018). Affected quantity: 19,944 Cartons (24 tablets each).

Recall Details

Product Type
Drugs
Report Date
December 27, 2017
Initiation Date
November 8, 2017
Termination Date
December 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19,944 Cartons (24 tablets each)

Product Description

Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01

Reason for Recall

Microbial Contamination of Non-Sterile Products

Distribution Pattern

Nationwide

Code Information

Lot # AF4273A; Exp. 02/18