Efficient Laboratories, Inc.: Drug Recall
Recall #D-0292-2022 · 08/24/2021
Class II: Risk
Recall Details
- Recall Number
- D-0292-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Efficient Laboratories, Inc.
- Status
- Terminated
- Date Initiated
- 08/24/2021
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 7,800 bottles; b) 16,417 bottles
Reason for Recall
Microbial Contamination of Non-Sterile Products
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Efficient Laboratories, Inc.
- Class II: Risk 08/24/2021
- Class II: Risk 08/24/2021
- Class II: Risk 08/24/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.