Recalls / Class II
Class IID-0237-2016
Product
Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.
- Affected lot / code info
- Lot Numbers: 20150408@10 BUD: 1/27/2015; 20151407@11 BUD: 1/10/2015; 20151604@8 9/16/2015; 20152703@2 9/16/2015
Why it was recalled
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recalling firm
- Firm
- US Compounding Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1270 Don's Lane, N/A, Conway, Arkansas 72032
Distribution
- Quantity
- 82 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-09-12
- FDA classified
- 2015-11-17
- Posted by FDA
- 2015-11-25
- Terminated
- 2017-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0237-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.