Why it was recalled
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Product description
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: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608
Lot numbers, UPCs & expiration codes
Lot #: 20K0043P, Exp. 8/31/2022; 20L0026P, Exp. 9/30/2022
Where it was sold
Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0330-2021
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Mar 19, 2021
- FDA report date
- Apr 21, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0330-2021, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 87548
- Address
- 379 Van Ness Ave Ste 1403
- Code information
- Lot #: 20K0043P, Exp. 8/31/2022; 20L0026P, Exp. 9/30/2022
- Postal code
- 90501-7211
- Report date
- Apr 21, 2021
- Product type
- Drugs
- Recall number
- D-0330-2021
- Classification
- Class III
- Recalling firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Reason for recall
- Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608
- Distribution pattern
- Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
- Recall initiation date
- Mar 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2021