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., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Class I - Dangerous

💊 Drugs Recalled: May 21, 2019 Torrent Pharma Prescription Drugs

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Torrent Pharma Inc
Reason for Recall:: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Product Codes/Lot Numbers:

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.