Recalls / Class II
Class IID-0128-2018
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
- Affected lot / code info
- Lot # AF4273A; Exp. 02/18
Why it was recalled
Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- L. Perrigo Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 19,944 Cartons (24 tablets each)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-11-08
- FDA classified
- 2017-12-21
- Posted by FDA
- 2017-12-27
- Terminated
- 2018-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0128-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.