The Recall Desk
SevereFDA (Drugs)·D-1360-2019·Announced 2019-06-19

Torrent Pharma Recalls Hyoscyamine Sulfate Elixir Due to Bacterial Contamination Risk

Torrent Pharma is recalling Hyoscyamine Sulfate Elixir 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 rating under the rubric for potential contamination with specific bacterial pathogens.

Plain-English summary

Torrent Pharma Inc is recalling 24,384 bottles of Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL (NDC:39328-048-16). The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).

The affected product is a prescription-only liquid medication distributed in 473 mL (16 oz.) bottles. The recall covers specific lots with expiration dates ranging from June 2019 to July 2020, including lot numbers 17F021, 17G013, 17K010, 18E015, 18F029, 18F031, 18F042, and 18G024.

The product was distributed to nine distributors, direct accounts, and relabelers who may have further distributed the medication throughout the United States. Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal.

The recalled product

Product
Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
Manufacturer
Torrent Pharma Inc
Category
Drug — Anticholinergic
Hazard
Affected units
24,384

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 (14)

  • Lot #s: 17F021
  • Exp. 06/2019
  • 17G013
  • Exp. 07/2019
  • 17K010
  • Exp. 10/2019
  • 18E015
  • Exp. 05/2020
  • 18F029
  • 18F031
  • 18F042
  • Exp. 06/2020
  • 18G024
  • Exp. 07/2020.

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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