Class II
Terminated
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.
- Company
- Pharma-Natural Inc.
- Recall Initiated
- June 21, 2019
- Posted
- July 31, 2019
- Recall Number
- D-1498-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 500 bottles
- Firm Location
- Miami Lakes, FL, United States
Reason for Recall
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Lot / Code Info
All lots remaining within expiry.
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