Home / Recalls / Efficient Laboratories, Inc. / D-0292-2022

D-0292-2022 Class II Terminated

Recalled by Efficient Laboratories, Inc. — Miami, FL

Recall Details

Product Type
Drugs
Report Date
December 29, 2021
Initiation Date
August 24, 2021
Termination Date
December 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 7,800 bottles; b) 16,417 bottles

Product Description

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

Reason for Recall

Microbial Contamination of Non-Sterile Products

Distribution Pattern

Nationwide within the United States

Code Information

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

Other recalls by Efficient Laboratories, Inc.

  • D-0293-2022 Class II — Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Dis (August 24, 2021)
  • D-0291-2022 Class II — Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories (August 24, 2021)
  • D-0290-2022 Class II — Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distrib (August 24, 2021)
  • D-0846-2020 Class II — Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient (January 31, 2020)
  • D-0845-2020 Class II — Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: (January 31, 2020)
  • D-0847-2020 Class II — New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: E (January 31, 2020)