Reported Jun 19, 2019 · Terminated

Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie…

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

- 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

Lot codes and dates: 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
Amount recalled: 24,384 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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