CLASS II Drug recall · Reported 29 Dec 2021 · FDA Enforcement Report
Rompe Pecho Max Multi-Symptoms Maximum Strength recalled
Efficient Laboratories is recalling Rompe Pecho Max Multi-Symptoms Maximum Strength, 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-0293-2022
- FDA event ID
- 89205
- Recalling firm
- Efficient Laboratories, Miami, FL
- 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
- Pain Medication
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 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
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 #: 19G219 Exp. July 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 89205| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rompe Pecho Ex Expectorant recalled by Efficient LaboratoriesRompe Pecho | 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 Ex Expectorant recalled by Efficient LaboratoriesRompe Pecho | 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 Acetaminophen recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |