Aurobindo Ranitidine Capsules 300 mg recalled over manufacturing violations
- Recall date
- November 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- AuroMedics Pharma LLC recalls Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton…
- Recall number
- D-0528-2020
- FDA classification
- Class II
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- nationwide
Why it was recalled
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
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