Recalls / Class II
Class IID-0276-2016
Product
Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
- Affected lot / code info
- Lot Code: 20150806@1 BUD: 12/5/2015, 20150806@2 BUD: 12/5/2015, 20151105@4 BUD: 11/7/2015, 20151105@6 BUD: 11/7/2015, 20151407@3 BUD: 1/10/2016, 20151603@1 BUD: 9/12/2015, 20151805@25 BUD: 11/14/2015, 20151805@28 BUD: 11/14/2015, 20152206@17 BUD: 12/19/2015, 20152707@1 BUD: 1/23/2016, 20153003@1 BUD: 9/26/2015, 20152003@2 BUD: 9/26/2015
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
- 14,580 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-0276-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.