Rompe Pecho Liquid
FDA Recall NDC 58593-829
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Rompe Pecho (NDC 58593-829). A significant event, classified as Class II, was initiated on Aug 24, 2021 by Efficient Laboratories Inc. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2021 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products
Aug 24, 2021
Dec 29, 2021
a) 7,800 bottles; b) 16,417 bottles
Recall Profile & Regulatory Data
Event ID
89205
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Efficient Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 08, 2022
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
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
58593-829-06Product
58593-829-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
