Reported Jun 19, 2019 · Terminated

Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin…

Torrent Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506

Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle
NDC39328-044-16, Patrin Pharma, Skokie, IL 60076

Lot codes and dates: 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
Amount recalled: 66,798 bottles

The agency filed one notice per product. You are reading one of them; the other 40 are below.

28 more are in the archive.

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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