FDAClass IIDecember 29, 2021

Rompe Pecho DM recall: Sterility Concern

Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06

Why was Rompe Pecho DM 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 #: 19F168 Exp. June 2022; 19G145, 19G361,19G449 19G491 Exp. July 2022.

Product
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Recalling firm
Efficient Laboratories, Inc.
Quantity
27,206 bottles
Distribution
Nationwide within the United States
Recall date
December 29, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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