Recalls / Class I
Class ID-1546-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
- Affected lot / code info
- Lot: 06062014@8, Do Not Use Beyond 12/03/2014
Why it was recalled
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Recalling firm
- Firm
- Pharmacy Creations
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 540 Route Ten West, Randolph, New Jersey 07869
Distribution
- Quantity
- 70 vials
- Distribution pattern
- NY, NJ, and Puerto Rico
Timeline
- Recall initiated
- 2014-06-25
- FDA classified
- 2014-08-19
- Posted by FDA
- 2014-08-27
- Terminated
- 2016-09-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1546-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.