Rompe Pecho Ex Expectorant — Class II drug recall D-0292-2022
Terminated recall by Efficient Laboratories, Inc., reported 2021-12-29, distributed nationwide. Microbial Contamination of Non-Sterile Products
| Recall number | D-0292-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Efficient Laboratories, Inc., Miami, FL, United States |
| Recall initiated | 2021-08-24 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2022-12-08 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| NDC | 58593-0829, 58593-0829-04, 58593-0829-06 |
| Expiration dates | 2022-01-20, 2022-05-20, 2022-08-20, 2022-09-20 |
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
Reason for recall
Microbial Contamination of Non-Sterile Products
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0292-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.