Drug product
ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.
D-1496-2019
Product summary
- Event
- Event 83190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1508 jars
- Official record key
drug-enforcement:D-1496-2019
Official wording
Reason: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Code information: All lots remaining within expiry.
Distribution pattern: Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations