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.
Reported: July 31, 2019 Initiated: June 21, 2019 #D-1503-2019
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.
Details
- Recalling Firm
- Pharma-Natural Inc.
- Units Affected
- 1000 jars
- 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? ▼
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.. Recalled by Pharma-Natural Inc.. Units affected: 1000 jars.
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-1503-2019.
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