Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Consumers and healthcare providers should stop using this product immediately. Contact ANTHONY TRINH, 123Herbals LLC or your healthcare provider for guidance. Notification method: Press Release
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SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.. Classification: Class I. Quantity: N/A. Distribution: USA nationwide
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Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Defective container; inadequately sealed blister packaging.