FDA Recall D-1546-2014
Pharmacy Creations · Randolph, NJ
Class I — life-threatening Terminated 817 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
Reason for recall
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Recall record
- Recall number
D-1546-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- NY, NJ, and Puerto Rico
- Recall initiated
- 2014-06-25
- Classified by FDA Center
- 2014-08-19
- FDA published
- 2014-08-27
- Terminated
- 2016-09-19
- Recalling firm
- Pharmacy Creations
- Firm location
- Randolph, NJ