Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc
Summary
The FDA issued a Class II for Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Dis by Efficient Laboratories, Inc.. Reason: Microbial Contamination of Non-Sterile Products.
Details
Source
Drug Recall
External ID
D-0293-2022
Action Date
2021-12-29
Status
Terminated
Category
drug
Product Description
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
Lot/Code Info: Lot #: 19G219 Exp. July 2022
Quantity Affected: 4,026 bottles
Reason for Recall
Microbial Contamination of Non-Sterile Products
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-24
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 27 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Efficient Laboratories, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Efficient Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Efficient Laboratories, Inc. have FDA actions?
Efficient Laboratories, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0293-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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