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Asclemed USA Inc. dba Enovachem Pharmaceuticals

Asclemed USA Inc. dba Enovachem Pharmaceuticals Recalls

All product recalls associated with Asclemed USA Inc. dba Enovachem Pharmaceuticals.

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Recall Summary

Total Recalls

6

Past Year

0

Class I (Serious)

2

Most Recent

Mar 2021

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–6 of 6 recalls

Methylprednisolone Tablets (DocRx) – Illegible Label (2021)

Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.

FDAMar 19, 2021AL, CA, IN +1 more• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Estriol Micronized (Enovachem) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class IIModerate

FDADec 9, 2019CA• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Estriol Micronized (Enovachem) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class II

Moderate

FDADec 9, 2019CA• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Estriol Micronized (Enovachem) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class IIModerate

FDADec 9, 2019CA• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Dyural-40 Injection Kit (Enovachem) – labeling issue (2018)

Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex

FDADec 11, 2018Nationwide• Asclemed USA Inc. dba Enovachem

Dyural-80 Injection Kit (Enovachem) – labeling issue (2018)

Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex

FDADec 11, 2018Nationwide• Asclemed USA Inc. dba Enovachem