Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Lot numbers, UPCs & expiration codes
Lot #: 19F168 Exp. June 2022; 19G145, 19G361,19G449 19G491 Exp. July 2022.
Where it was sold
Nationwide within the United States
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-0291-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2021
- FDA report date
- Dec 29, 2021
- Quantity
- 27,206 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Efficient Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0291-2022, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89205
- Address
- 7715 NW 64th St
- Code information
- Lot #: 19F168 Exp. June 2022; 19G145, 19G361,19G449 19G491 Exp. July 2022.
- Postal code
- 33166-2719
- Report date
- Dec 29, 2021
- Product type
- Drugs
- Recall number
- D-0291-2022
- Classification
- Class II
- Recalling firm
- Efficient Laboratories, Inc.
- Product quantity
- 27,206 bottles
- Termination date
- Dec 8, 2022
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 24, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2021