The Recall Desk
SevereFDA (Drugs)·D-1365-2019·Announced 2019-06-19

Torrent Pharma Recalls Phenobarbital Oral Solution Due to Potential Bacterial Contamination

Torrent Pharma is recalling Phenobarbital Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential contamination with specific bacterial pathogens.

Plain-English summary

Torrent Pharma Inc. is recalling 148,440 bottles of Phenobarbital Oral Solution, USP, 20 mg per 5 mL, One Pint (473 mL) bottle. The product is identified by NDC 16571-330-16 and was manufactured by Bio-Pharm Inc. and distributed by Rising Pharmaceuticals Inc.

The recall was initiated due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The affected lots include 17E007, 17F026, 17G015, 17K002, 17K026, 17M002, 18C020, 18D023, 18F009, and 18K030, with expiration dates ranging from May 2019 to October 2020.

The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

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.
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
148,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 41 recalled by Torrent Pharma Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

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