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
Reported: December 4, 2019 Initiated: November 6, 2019 #D-0528-2020
Product Description
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
Reason for Recall
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 134,160 bottles
- Distribution
- nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product 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. Recalled by AuroMedics Pharma LLC. Units affected: 134,160 bottles.
Why was this product recalled? ▼
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 4, 2019. Severity: Moderate. Recall number: D-0528-2020.
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