Reported Jun 19, 2019 · Terminated

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains…

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

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle
NDC
- 0904-1228-00
- b) One Pint (473 mL) bottle
NDC
- 0904-5174-16
- Distributed by Major Pharmaceuticals
- Livonia MI 48152

Lot codes and dates: 99 of 99 codes
Lot #s: a)17E018
17E020
17E026
Exp. 05/2019
17H008
17H018
17H028
Exp. 08/2019
17J002
17J025
17J028
Exp. 09/2019
17L035
Exp. 11/2019
17M024
Exp. 12/2019
18A017
Exp. 01/2020
18B016
Exp. 02/2020
18C011
Exp. 03/2020
18D014
18D021
18D026
Exp. 04/2020
18E014
Exp. 05/2020
18F036
Exp. 06/2020
18F035
18G018
Exp. 07/2020
18H005
18H015
Exp. 08/2020
19A011
19A013
Exp. 01/2121. b) 17E013
17E025
17E028
17E041
Exp. 05/2019
17F009
17F016
Exp. 06/2019
17G007
17G021
17G032
Exp. 07/2019
17H023
Exp. 08/2019
17J001
17J012
17J023
17J027
Exp. 09/2019
17K004
17K022
17K028
Amount recalled: 655,104 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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