Class II
Terminated
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
This recall has been terminated (originally issued November 20, 2019).
- Company
- Novitium Pharma Llc
- Recall Initiated
- October 25, 2019
- Posted
- November 20, 2019
- Recall Number
- D-0310-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 19560 bottles
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
Nationwide
Lot / Code Info
all lots within expiry.
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