Recalls / Class II
Class IID-1265-2016
Product
Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72
- Affected lot / code info
- All Sterile Compounded Products within Expiry
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharmakon Pharmaceuticals, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 14450 Getz Rd, Noblesville, Indiana 46060-3303
Distribution
- Quantity
- 280
- Distribution pattern
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Timeline
- Recall initiated
- 2016-04-20
- FDA classified
- 2016-07-11
- Posted by FDA
- 2016-07-20
- Terminated
- 2018-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1265-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.