Recalls / Class II
Class IID-1724-2019
Product
CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
- Affected lot / code info
- Lot #'s 52J17, 53J17, 54J17, 55J17, 59J17, 60J17 EXP 07/2019
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
- 144 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-1724-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.