Recalls / Class II
Class IID-0293-2022
Product
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
- Brand name
- Rompe Pecho Max Multi Symptoms
- Generic name
- Acetaminophen, Dextromethophan Hbr, Phenylephrine Hcl, Guaifenesin
- Active ingredients
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Route
- Oral
- NDC
- 58593-828
- FDA application
- M012
- Affected lot / code info
- Lot #: 19G219 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
- 4,026 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-0293-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.