FDAClass IIFebruary 19, 2020

Rompe Pecho EX Expectorant recall: Sterility Concern

Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1

Why was Rompe Pecho EX Expectorant recalled?

Microbial Contamination of Non-Sterile Products

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 19F332 Exp. June 2022

Product
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
Recalling firm
Efficient Laboratories, Inc.
Quantity
5387 6 Fl Oz bottles
Distribution
Distributed Nationwide in the USA
Recall date
February 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls