The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1359-2019·Announced 2019-06-19

Torrent Pharma Recalls Hyoscyamine Oral Drops Due to Bacterial Contamination Risk

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves potential contamination with specific bacterial pathogens, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Torrent Pharma Inc is recalling 53,520 bottles of Hyoscyamine Oral Drops 0.125 mg/mL, 15 mL bottles. The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations that created a potential for product contamination with Burkholderia cepacia and Ralstonia pickettii.

The affected product is identified by NDC 39328-047-15 and includes lot numbers 17E039, 17K016, 18E021, and 18G008. 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 the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or pharmacy of purchase. This recall is classified as Class II by the FDA.

The recalled product

Product
Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Liquid
Hazard
Affected units
53,520

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 (8)

  • Lot #s: 17E039
  • Exp. 05/2019
  • 17K016
  • Exp. 10/2019
  • 18E021
  • Exp. 05/2020
  • 18G008
  • 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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