Rompe Pecho EX Expectorant — Class II drug recall D-0846-2020
Terminated recall by Efficient Laboratories, Inc., reported 2020-02-19, distributed nationwide. Microbial Contamination of Non-Sterile Products
| Recall number | D-0846-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Efficient Laboratories, Inc., Miami, FL, United States |
| Recall initiated | 2020-01-31 |
| Classified | 2020-02-14 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 5,387 |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00000856301061 |
| Lot numbers | 19F332 |
| Expiration dates | 2022-06-20 |
Product
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
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-0846-2020. 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.