The Recall Desk
SevereFDA (Drugs)·D-1358-2019·Announced 2019-06-19

Torrent Pharma Recalls Cyproheptadine Syrup Due to Bacterial Contamination Risk

Torrent Pharma is recalling Cyproheptadine Hydrochloride Syrup 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, and the presence of specific bacterial contaminants (Burkholderia cepacia and Ralstonia pickettii) in an oral solution presents a significant risk of infection, meeting the criteria for a Severe rating.

Plain-English summary

Torrent Pharma Inc is recalling 66,798 bottles of Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16. The recall is due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).

The affected product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. The recall includes specific lot numbers with expiration dates ranging from May 2019 to July 2020.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
66,798

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: 17L003
  • Exp. 05/2019
  • 18A021
  • Exp. 07/2019
  • 18C027
  • Exp. 09/2019
  • 18D020
  • Exp. 10/2019
  • 18E007
  • 18E022
  • Exp. 11/2019
  • 18F006
  • 18F007
  • 18F023
  • 18F023A
  • 18F040
  • Exp. 12/2019
  • 19A004
  • 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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