Drug product
Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
D-0071-2021
Product summary
- Event
- Event 86712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 939 jars
- Official record key
drug-enforcement:D-0071-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #: H20-01S thru H20-12S
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations