Torrance, CA, United States
Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls
2 recalls recorded since 2018, most recently on 19 March 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 19 March 2021
- Reason
- Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
- Distribution
- Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0330-2021
- Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubila
Terminated Class II Drugs
- Recall started
- 9 December 2019
- Terminated
- 9 August 2023
- Reason
- Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
- Distribution
- Product was distributed to 6 physician's offices within the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0650-2020, D-0651-2020, D-0652-2020
- Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
- Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
- Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.