Drug product
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.
D-1135-2017
Product summary
- Event
- Event 78049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 bottles
- Official record key
drug-enforcement:D-1135-2017
Official wording
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot: 23221701, Exp. 05/19
Distribution pattern: TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations