Reported Dec 29, 2021 · Terminated

Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL)…

Efficient Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Efficient Laboratories, Inc. · 7715 NW 64th St · Miami, FL · 33166-2719

Is this the product you have?

  • 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
Lot codes and dates
    • 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
Amount recalled
a) 7,800 bottles; b) 16,417 bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 8, 2022 · Data as of Sep 19, 7:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.