Could cause temporary or reversible harm; serious harm is unlikely.
Microbial Contamination of Non-Sterile Products
| Brand name | ROMPE PECHO MAX MULTI SYMPTOMS |
| Generic name | ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN |
| Active ingredient(s) | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE |
| Distributed by / for | Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5 |
| NDC | 58593-828-08 |
| Full product label | 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 |
| Recalling firm | Efficient Laboratories, Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 4,026 bottles |
| Recall initiated | 2021-08-24 |
| Report date | 2021-12-29 |
| Recall completed | 2022-12-08 |
| Recall number | D-0293-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Miami FL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗