FDA Drug Recalls

Recalls / Class II

Class IID-0847-2020

Product

New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5

Affected lot / code info
Lot: 19B42 Exp. February 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
4080 8 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-0847-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.