Drug recall
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient…
FDA recall event 89205 · Class II · Efficient Laboratories, Inc.
Key facts
| Event ID | 89205 |
|---|---|
| Recall numbers | D-0290-2022, D-0291-2022, D-0292-2022, D-0293-2022 |
| Recalling firm | Efficient Laboratories, Inc. |
| Product type | Drugs |
| Products | Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06, Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06, 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, 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products |
| Initiation date | Aug 24, 2021 |
| Report date | Dec 29, 2021 |
| Termination date | Dec 8, 2022 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3002966766 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: