FDA Recall D-0305-2015
Pharmacy Creations · Randolph, NJ
Class I — life-threatening Terminated 304 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, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Reason for recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Recall record
- Recall number
D-0305-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
- Recall initiated
- 2014-09-05
- Classified by FDA Center
- 2014-12-19
- FDA published
- 2014-12-31
- Terminated
- 2015-07-06
- Recalling firm
- Pharmacy Creations
- Firm location
- Randolph, NJ