DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Reported: July 31, 2019 Initiated: June 21, 2019 #D-1498-2019
Product Description
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Reason for Recall
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Details
- Recalling Firm
- Pharma-Natural Inc.
- Units Affected
- 500 bottles
- Distribution
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.. Recalled by Pharma-Natural Inc.. Units affected: 500 bottles.
Why was this product recalled? ▼
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1498-2019.
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