Class II · Moderate risk
Rompe Pecho Max Multi-Symptoms Maximum Strength
Microbial Contamination of Non-Sterile Products
Rompe Pecho Ex Expectorant (Guaifenesin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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
Affected NDCs
58593-0829-04
58593-0829-06
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Rompe Pecho EX Guaifenesin NDC 58593-0829 |
200 mg/10mL | Liquid Oral |
Efficient Laboratories Inc | OTC |
- Recalling firm
- Efficient Laboratories, Inc.
- NDC code
- 58593-829-04
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0292-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Efficient Laboratories, Inc.
All 2021 recalls
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