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
Reported: November 20, 2019 Initiated: October 25, 2019 #D-0310-2020
Product Description
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
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Novitium Pharma LLC
- Units Affected
- 19560 bottles
- Distribution
- Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Novitium Pharma LLC. Units affected: 19560 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0310-2020.
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