Multi-event December 2019 FDA Recall Drug by Asclemed Usa Inc. Dba Enovachem Pharmaceuticals
This Multi-event Class II drug recall was voluntarily initiated by Asclemed Usa Inc. Dba Enovachem Pharmaceuticals on December 9, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed to 6 physician's offices within the state of California. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0652-2020
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
12-09-2019
01-15-2020
56.4 gm
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 6 physician's offices within the state of California.
08-09-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Batch or Lot Expiration Information
Lot# Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161902, EXP 12/31/2020; 09161901, 10091905, 10221902, 10311901, EXP 5/31/2021; 11211902, 10311902, EXP 8/31/2021
Recall Number: D-0651-2020
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
12-09-2019
01-15-2020
42.12 gm
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 6 physician's offices within the state of California.
08-09-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Batch or Lot Expiration Information
Lot# Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021
Recall Number: D-0650-2020
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
12-09-2019
01-15-2020
8.52 gm
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 6 physician's offices within the state of California.
08-09-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Batch or Lot Expiration Information
Lot# Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020
