Recalls / Class II
Class IID-862-2013
Product
Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Affected lot / code info
- All lots within expiry
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recalling firm
- Firm
- Pallimed Solutions
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 400 W Cummings Park, Woburn, Massachusetts 01801-6519
Distribution
- Quantity
- 71 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-25
- FDA classified
- 2013-08-09
- Posted by FDA
- 2013-08-21
- Terminated
- 2013-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-862-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.