Why it was recalled
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Product description
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.
Lot numbers, UPCs & expiration codes
Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17
Where it was sold
Nationwide
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-0567-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2015
- FDA report date
- Jan 20, 2016
- Quantity
- 20 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Freedom Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0567-2016, exactly as published.
Show all FDA fields
- City
- Broken Arrow
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 72795
- Address
- 801 W New Orleans St
- Code information
- Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17
- Postal code
- 74011-1844
- Report date
- Jan 20, 2016
- Product type
- Drugs
- Recall number
- D-0567-2016
- Classification
- Class II
- Recalling firm
- Freedom Pharmaceuticals Inc
- Product quantity
- 20 kg
- Termination date
- Jun 24, 2016
- Reason for recall
- Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2016