FDAFDA · Food and drugs·Recall number D-0292-2022
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
Published December 29, 2021 · Recall initiated: August 24, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ROMPE PECHO
- Manufacturer
- Efficient Laboratories, Inc.
- Distributor
- Nationwide within the United States
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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