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

Recall Number: D-0292-2022

Firm: Efficient Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20211229

Initiation Date: 20210824

Termination Date: 20221208

Microbial Contamination of Non-Sterile 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