Reported Jun 19, 2019 · Terminated

Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b)…

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

Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle
NDC
- 0536-0770-97
- b) One Pint (473 mL) bottle
NDC0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152

Lot codes and dates: Lot #s: a) 17H025
Exp. 08/2019
17M022
Exp. 12/2019
18E011
Exp. 05/2020
18G018
Exp. 07/2020
18J014
Exp. 09/2020. b) 17E010
17E030
Exp. 05/2019
17F013
Exp. 06/2019
17F010
Exp. 07/2019
17J014
Exp. 09/2019
17L005
Exp. 11/2019
17M017
Exp. 12/2019
18A022
Exp. 01/2020
18B021
Exp. 02/2020 18D017
Exp. 04/2020
18E011
Exp. 05/2020
18F041
Exp. 06/2020
18G021
18H022
18H028
18H030
Exp. 08/2020
Amount recalled: 438,624 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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