D-0128-2018 Class II Terminated
FDA drug recall D-0128-2018 was initiated by L. Perrigo Company on Nov 8, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products The recall status is terminated (terminated Dec 13, 2018). Affected quantity: 19,944 Cartons (24 tablets each).
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 27, 2017
- Initiation Date
- Nov 8, 2017
- Termination Date
- Dec 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0128-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026