D-1135-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- August 30, 2017
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 bottles
Product Description
Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.
Reason for Recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Distribution Pattern
TX
Code Information
Lot: 23221701, Exp. 05/19