Recalls / Class II
Class IID-0290-2022
Product
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06
- Brand name
- Rompe Pecho
- Generic name
- Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
- Active ingredients
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Route
- Oral
- NDC
- 58593-235
- FDA application
- M012
- Affected lot / code info
- Lot #: 19F88 Exp. June 2022; 19G164 Exp. July 2022.
Why it was recalled
Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- Efficient Laboratories, Inc.
- Manufacturer
- Efficient Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7715 NW 64th St, N/A, Miami, Florida 33166-2719
Distribution
- Quantity
- 10,833 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-08-24
- FDA classified
- 2021-12-22
- Posted by FDA
- 2021-12-29
- Terminated
- 2022-12-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0290-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.