Class II
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) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
This recall has been terminated (originally issued December 29, 2021).
- Company
- Efficient Laboratories, Inc.
- Recall Initiated
- August 24, 2021
- Posted
- December 29, 2021
- Recall Number
- D-0292-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 7,800 bottles; b) 16,417 bottles
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination of Non-Sterile Products
Distribution
Nationwide within the United States
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
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