D-1498-2019 Class II Terminated
FDA drug recall D-1498-2019 was initiated by Pharma-Natural Inc. on June 21, 2019 and is designated Class II. Reason for recall: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. The recall status is terminated (terminated October 27, 2021). Affected quantity: 500 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- June 21, 2019
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 bottles
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.
Distribution Pattern
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Code Information
All lots remaining within expiry.