Recalls / Class II
Class IID-0529-2020
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
- Affected lot / code info
- UI1519001-A UI1519002-A UI1519003-A UI1519004-A
Why it was recalled
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 19320 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2019-11-06
- FDA classified
- 2019-11-26
- Posted by FDA
- 2019-12-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0529-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.