Drug product
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
D-0529-2020
Product summary
- Event
- Event 84218
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19320 bottles
- Official record key
drug-enforcement:D-0529-2020
Official wording
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Code information: UI1519001-A UI1519002-A UI1519003-A UI1519004-A
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations