Rompe Pecho Ex Expectorant recalled over sterility concerns
- Recall date
- August 24, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Efficient Laboratories, Inc. recalls Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottle…
- Recall number
- D-0292-2022
- FDA classification
- Class II
- Brand / firm
- Efficient Laboratories, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Microbial Contamination of Non-Sterile Products
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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