Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 19B42 Exp. February 2022
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0847-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 31, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 4080 8 FL Oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Efficient Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0847-2020, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 84864
- Address
- 7715 NW 64th St
- Code information
- Lot: 19B42 Exp. February 2022
- Postal code
- 33166-2719
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0847-2020
- Classification
- Class II
- Recalling firm
- Efficient Laboratories, Inc.
- Product quantity
- 4080 8 FL Oz bottles
- Termination date
- Oct 22, 2020
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jan 31, 2020
- Initial firm notification
- Press Release
- Center classification date
- Feb 14, 2020