Recalls / Class II
Class IID-1730-2019
Product
Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
- Affected lot / code info
- Lot #'s 68J17, 71J17, 72J17, 73J17, 77J17, 78J17, 79J17, 81J17, 82J17 - EXP 07/2019; 27P17, 28P17, 29P17, 30P17, 31P17, 32P17, 33P17, 37P17, 38P17, EXP 11/2019.
Why it was recalled
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recalling firm
- Firm
- US Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 681 Main St Ste 27, N/A, Belleville, New Jersey 07109-3471
Distribution
- Quantity
- 880 cases
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2019-07-11
- FDA classified
- 2019-08-13
- Posted by FDA
- 2019-08-21
- Terminated
- 2020-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1730-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.