CLASS II Drug recall · Reported 29 Dec 2021 · 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 24 Aug 2021 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-0292-2022
- FDA event ID
- 89205
- Recalling firm
- Efficient Laboratories, Miami, FL
- Brand
- Rompe Pecho
- Manufacturer
- Efficient Laboratories Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2021
- FDA classified
- 22 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 24 Aug 2021 | Recall initiated by company | |
| 22 Dec 2021 | Classified by FDA | +120 days |
| 29 Dec 2021 | Published in enforcement report | +7 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, 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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products
Which lots are affected?
Lot #: a) 19H20 Exp. August 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022; b) 19H20 Exp. August 2022; 19J98 Exp. September 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022
Where was it sold?
Nationwide within the United States
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
3 other products · FDA event 89205This product is part of a recall event; the main page for the event is Rompe Pecho Max Multi-Symptoms Maximum Strength recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rompe Pecho Max Multi-Symptoms Maximum Strength recalledRompe Pecho Max Multi Symptoms | Efficient Laboratories | Sterility | Nationwide | |
| CLASS II | Rompe Pecho CF Cold & Flu Advanced Formula recalledRompe Pecho | Efficient Laboratories | Sterility | Nationwide | |
| CLASS II | Rompe Pecho DM recalled by Efficient LaboratoriesRompe Pecho | 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 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 |
| Drug | CLASS II | Rompe Pecho EX Expectorant recalled by Efficient Laboratories | Efficient Laboratories | Sterility | Nationwide |
Other Guaifenesin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI HoldingsGuaifenesin And Codeine Phosphate | PAI Holdings | Potency & Assay | OH |
| Drug | CLASS II | Guaifenesin Oral Solution, 300 mg/, Sugar Free/Alcohol Free recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Mucinex DM (guaifenesin 600mg recalled by Reckitt BenckiserMucinex Dm | Reckitt Benckiser | Packaging Defects | Nationwide |