Recalls / Class II
Class IID-1726-2019
Product
CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
- Affected lot / code info
- Lot #'s 28L17, 31L17, 36L17, 40L17, 44L17 EXP 09/2019; 05M17, 09M17, 12M17, 13M17, 23M17 EXP 10/2019; 69P17, 72P17 EXP 11/2019; 42S17, 46S17 EXP 12/2019; 85C18, 86C18 EXP 03/2020; 31J18, 43J18, 55J18, 58J18, 18L18 EXP 07/2020.
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
- 5017 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-1726-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.