Drug product
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
D-0292-2022
Product summary
- Event
- Event 89205
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 7,800 bottles; b) 16,417 bottles
- Official record key
drug-enforcement:D-0292-2022
Official wording
Reason: Microbial Contamination of Non-Sterile Products
Code information: Lot #: a) 19H20 Exp. August 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022; b) 19H20 Exp. August 2022; 19J98 Exp. September 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Microbial contamination
Microbial Contamination