Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Ma…
- Recall date
- May 26, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1314-2020
- FDA classification
- Class III
- Brand / firm
- Aurobindo Pharma USA Inc.
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Failed Impurities/ Degradation Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
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