MethylPREDNISolone Tablets recalled over manufacturing violations
- Recall date
- May 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India ND…
- Recall number
- D-1451-2019
- FDA classification
- Class II
- Brand / firm
- Zydus Pharmaceuticals USA Inc
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
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