Drug product
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
D-0128-2018
Product summary
- Event
- Event 78520
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,944 Cartons (24 tablets each)
- Official record key
drug-enforcement:D-0128-2018
Official wording
Reason: Microbial Contamination of Non-Sterile Products
Code information: Lot # AF4273A; Exp. 02/18
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination