Recalls / Class II
Class IID-0292-2022
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
- Brand name
- Rompe Pecho
- Generic name
- Guaifenesin
- Active ingredient
- Guaifenesin
- Route
- Oral
- NDC
- 58593-829
- FDA application
- M012
- Affected lot / code info
- 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
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
- a) 7,800 bottles; b) 16,417 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-0292-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.