Class II · Moderate risk
Rompe Pecho Max Multi-Symptoms Maximum Strength
Microbial Contamination of Non-Sterile Products
New! Rompe Pecho MAX Multi Symptoms
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
New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
- Recalling firm
- Efficient Laboratories, Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0847-2020 · 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 2020 recalls
Class II · Moderate risk
Rompe Pecho Ex Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho DM
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu Advanced Formula
Microbial Contamination of Non-Sterile Products
Other microbial contamination recalls from 2020
All microbial contamination recalls
Class II · Moderate risk
Paroex (Chlorhexidine Gluconate)
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class I · High risk
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk
Chlorhexidine Gluconate Oral Rinse USP
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
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