FDA-Drug2021-12-29Class II
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
Efficient Laboratories, Inc.
Hazard
Microbial Contamination of Non-Sterile Products
Sold states
Nationwide within the United States
Affected count
a) 7,800 bottles; b) 16,417 bottles
Manufactured in
7715 NW 64th St, N/A, Miami, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2022Don't want to check this manually?
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