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.
Reported: June 19, 2019 Initiated: May 21, 2019 #D-1365-2019
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).
Details
- Recalling Firm
- Torrent Pharma Inc
- Units Affected
- 148,440 bottles
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Location
- Levittown, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Torrent Pharma Inc. Units affected: 148,440 bottles.
Why was this product recalled? ▼
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Moderate. Recall number: D-1365-2019.
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