D-1503-2019 Class II Terminated
FDA drug recall D-1503-2019 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: 1000 jars.
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
- 1000 jars
Product Description
Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
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.