Multi event Drug Recall Enforcement Report Class II voluntary initiated by Efficient Laboratories, Inc., originally initiated on 08-24-2021 for the product 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 The product was recalled due to microbial contamination of non-sterile products. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0292-2022 | 08-24-2021 | 12-29-2021 | Class II | a) 7,800 bottles; b) 16,417 bottles | 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 | Microbial Contamination of Non-Sterile Products | Terminated |
| D-0291-2022 | 08-24-2021 | 12-29-2021 | Class II | 27,206 bottles | Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06 | Microbial Contamination of Non-Sterile Products | Terminated |
| D-0293-2022 | 08-24-2021 | 12-29-2021 | Class II | 4,026 bottles | 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 | Microbial Contamination of Non-Sterile Products | Terminated |
| D-0290-2022 | 08-24-2021 | 12-29-2021 | Class II | 10,833 bottles | 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 | Microbial Contamination of Non-Sterile Products | Terminated |
Recalled Products
