Drug product
Dr. King's SafeCare Rx GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000723, NDC 57955-0007-2
D-0886-2019
Product summary
- Firm
- King Bio Inc.
- Event
- Event 80601
- Status
- Terminated
- Classification
- Class I
- Quantity
- 95 bottles
- Official record key
drug-enforcement:D-0886-2019
Official wording
Reason: Microbial contamination
Code information: Lots: 091015F Exp. 09/18; 100416C Exp. 10/19
Distribution pattern: U.S.A. Nationwide, Canada, and Australia.
Derived failure modes
-
Microbial contamination
Microbial contamination