Drug product
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
D-0846-2020
Product summary
- Event
- Event 84864
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5387 6 Fl Oz bottles
- Official record key
drug-enforcement:D-0846-2020
Official wording
Reason: Microbial Contamination of Non-Sterile Products
Code information: Lot: 19F332 Exp. June 2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination