Reported Jun 19, 2019 · Terminated

Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories…

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

- Laxative Suppositories (Bisacodyl USP
- 10 mg)
- a) 12 Suppositories per carton
NDC
- 0536-1355-12
- b) 100 Suppositories per carton
NDC0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152

Lot codes and dates: Lot #s: a) 17K009
Exp. 10/2019
17M028
Exp. 12/2019
18F003
Exp. 06/2020
18J022
Exp. 09/2020
18L012
Exp. 11/2020
19A008
Exp. 01/2021. b) 17G004
17G028
Exp. 07/2019
18A034
Exp. 01/2020
18C016
Exp. 03/2020
18E005
Exp. 05/2020
18F038
Exp. 06/2020
18G015
Exp. 07/2020
18H024
Exp. 08/2020
18K024
Exp. 10/2020
18L011
Exp. 11/2020
19A009
Exp. 01/2021
18D033
Exp. 04/2020
18E025
Exp. 05/2020
Amount recalled: 120,204 cartons

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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