FDA Drug Recalls

Recalls / Class II

Class IID-0845-2020

Product

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

Affected lot / code info
Lot: 19H359 Exp. August 2022

Why it was recalled

Microbial Contamination of Non-Sterile Products

Recalling firm

Firm
Efficient Laboratories, Inc.
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
7715 NW 64th St, Miami, Florida 33166-2719

Distribution

Quantity
5249 6 Fl Oz bottles
Distribution pattern
Distributed Nationwide in the USA

Timeline

Recall initiated
2020-01-31
FDA classified
2020-02-14
Posted by FDA
2020-02-19
Terminated
2020-10-22
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0845-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls