Reported Jun 19, 2019 · Terminated

Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per…

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

- Biscolax Laxative (Bisacodyl
- USP 10 mg)
- a) 12 suppositories per carton
NDC
- 0904-5058-12
- b) 100 suppositories per carton
NDC
- 0904-5058-60
- Distributed by Major Pharmaceuticals Inc
- Livonia MI 48152

Lot codes and dates: 69 of 69 codes
Lot #s: a) 17E004
17E033
Exp. 05/2019
17F019
Exp. 06/2019
17G017
Exp. 07/2019
17K009
17K030
Exp. 10/2019
17M006
17M028
Exp. 12/2019
18A029
Exp. 01/2020
18C037
Exp. 03/2020
18E002
Exp. 05/2020
18F003
18F013
Exp. 06/2020
18G002
18G016
Exp. 07/2020
18H031
Exp. 08/2020
18J004
09/2020
18L008
18L012
Exp. 11/2020
19A008
Exp. 01/2021. b) 17E005
17E027
Exp. 05/2019
17K025
Exp. 10/2019
17M006
Exp. 12/2019
18A014
Exp. 01/2020
18B039
Exp. 02/2020
18C037
Exp. 03/2020
18D033
Exp. 04/2020
18E025
Exp. 05/2020
18F013
18F018
Exp. 06/2020
18G003
Exp. 07/2020
18H012
18H014
Exp. 08/2020
18J026
Exp. 09/2020
Amount recalled: 391,404 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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