D-1365-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148,440 bottles
Product Description
Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution Pattern
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Code Information
Lot #s: 17E007, Exp. 05/2019; 17F026, Exp. 06/2019; 17G015, Exp. 07/2019; 17K002; 17K026, Exp. 10/2019; 17M002, Exp. 12/2019; 18C020, Exp. 03/2020; 18D023, Exp. 04/2020; 18F009, Exp. 06/2020; 18K030, Exp. 10/2020.