Recalls / Class II
Class IID-1365-2019
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- Torrent Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- 148,440 bottles
- Distribution pattern
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1365-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.