Doctor Manzanilla Cough & Cold (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 00316 1.
Reported: September 20, 2017 Initiated: August 30, 2017 #D-1136-2017
Product Description
Doctor Manzanilla Cough & Cold (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 00316 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.
Details
- Recalling Firm
- Mid Valley Pharmaceutical
- Units Affected
- 24 bottles
- Distribution
- TX
- Location
- Raymondville, TX
Frequently Asked Questions
What product was recalled? ▼
Doctor Manzanilla Cough & Cold (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 00316 1.. Recalled by Mid Valley Pharmaceutical. Units affected: 24 bottles.
Why was this product recalled? ▼
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 20, 2017. Severity: Moderate. Recall number: D-1136-2017.
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