CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Rompe Pecho EX Expectorant recalled by Efficient Laboratories
Efficient Laboratories is recalling Rompe Pecho EX Expectorant, distributed nationwide in the US. The recall was initiated on 31 Jan 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0846-2020
- FDA event ID
- 84864
- Recalling firm
- Efficient Laboratories, Miami, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jan 2020
- FDA classified
- 14 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 31 Jan 2020 | Recall initiated by company | |
| 14 Feb 2020 | Classified by FDA | +14 days |
| 19 Feb 2020 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products
Which lots are affected?
Lot: 19F332 Exp. June 2022
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84864This product is part of a recall event; the main page for the event is New! Rompe Pecho MAX Multi Symptoms recalled by Efficient Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | New! Rompe Pecho MAX Multi Symptoms recalled by Efficient Laboratories | Efficient Laboratories | Sterility | Nationwide | |
| CLASS II | Rompe Pecho CF Cold & Flu with Honey recalled by Efficient Laboratories | Efficient Laboratories | Sterility | Nationwide |
More recalls from Efficient Laboratories
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rompe Pecho DM recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho CF Cold & Flu Advanced Formula recalledRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho Ex Expectorant recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho Max Multi-Symptoms Maximum Strength recalledRompe Pecho Max Multi Symptoms | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho CF Cold & Flu with Honey recalled by Efficient Laboratories | Efficient Laboratories | Sterility | Nationwide |