Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: a) 19H20 Exp. August 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022; b) 19H20 Exp. August 2022; 19J98 Exp. September 2022; 19A418 Exp. January 2022; 19E411 Exp. May 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-0292-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2021
- FDA report date
- Dec 29, 2021
- Quantity
- a) 7,800 bottles; b) 16,417 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Efficient Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0292-2022, 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 #: a) 19H20 Exp. August 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022; b) 19H20 Exp. August 2022; 19J98 Exp. September 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022
- Postal code
- 33166-2719
- Report date
- Dec 29, 2021
- Product type
- Drugs
- Recall number
- D-0292-2022
- Classification
- Class II
- Recalling firm
- Efficient Laboratories, Inc.
- Product quantity
- a) 7,800 bottles; b) 16,417 bottles
- Termination date
- Dec 8, 2022
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 24, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2021