FDAFDA · Food and drugs·Recall number D-1205-2018
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Published September 26, 2018 · Recall initiated: August 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- Product was distributed throughout the United States.
- Lot
- Lot # 17P0078, exp. date 12/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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