Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product description
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
Lot numbers, UPCs & expiration codes
Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21
Where it was sold
Nationwide in the USA
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-1449-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 6, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1449-2019, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82827
- Address
- 73 Route 31 N
- Code information
- Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21
- Postal code
- 08534-3601
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1449-2019
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Termination date
- Sep 16, 2021
- Reason for recall
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 1, 2019