Why it was recalled
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Product description
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Lot numbers, UPCs & expiration codes
Lot #: 0855, Exp. 8/31/ 2025
Where it was sold
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
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-0557-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2024
- FDA report date
- Jun 26, 2024
- Quantity
- 113,544 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denison Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0557-2024, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- RI
- Status
- Terminated
- Country
- United States
- Event ID
- 94712
- Address
- 1 Powder Hill Rd
- Code information
- Lot #: 0855, Exp. 8/31/ 2025
- Postal code
- 02865-4407
- Report date
- Jun 26, 2024
- Product type
- Drugs
- Recall number
- D-0557-2024
- Classification
- Class II
- Recalling firm
- Denison Pharmaceuticals, LLC
- Product quantity
- 113,544 bottles
- Termination date
- Aug 26, 2025
- Reason for recall
- cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
- Distribution pattern
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Recall initiation date
- May 28, 2024
- Center classification date
- Jun 17, 2024