Recalls / Class II
Class IID-0706-2016
Product
papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Affected lot / code info
- All lots
Why it was recalled
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recalling firm
- Firm
- Abbott's Compounding Pharmacy, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2320 Woolsey St, Berkeley, California 94705-1973
Distribution
- Quantity
- 10 ml
- Distribution pattern
- CA
Timeline
- Recall initiated
- 2016-01-15
- FDA classified
- 2016-02-17
- Posted by FDA
- 2016-02-24
- Terminated
- 2017-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0706-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.