D-0567-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 20, 2016
- Initiation Date
- March 10, 2015
- Termination Date
- June 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kg
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.
Reason for Recall
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Distribution Pattern
Nationwide
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