FDA Recall D-0526-2020
AuroMedics Pharma LLC · East Windsor, NJ
Class II Ongoing 2381 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
Reason for recall
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recall record
- Recall number
D-0526-2020- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- nationwide
- Recall initiated
- 2019-11-06
- Classified by FDA Center
- 2019-11-26
- FDA published
- 2019-12-04
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.