Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets p...

FDA Recall #D-0128-2018 — Class II — November 8, 2017

Recall #D-0128-2018 Date: November 8, 2017 Classification: Class II Status: Terminated

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

Recalling Firm

L. Perrigo Company — Allegan, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

19,944 Cartons (24 tablets each)

Distribution

Nationwide

Code Information

Lot # AF4273A; Exp. 02/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated