Novitium Pharma product recalled over manufacturing violations
- Recall date
- October 25, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Novitium Pharma LLC recalls Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East…
- Recall number
- D-0312-2020
- FDA classification
- Class II
- Brand / firm
- Novitium Pharma LLC
- Sold / distributed
- Nationwide
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
Get recall alerts
Free email alert whenever Novitium Pharma LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Novitium Pharma LLC