Recalls / Class II
Class IID-0238-2016
Product
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
- Affected lot / code info
- Lot Numbers: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015
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
- 19,494 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-0238-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.