Recalls / Class II
Class IID-1086-2018
Product
Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
- Affected lot / code info
- All lots within expiry
Why it was recalled
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Recalling firm
- Firm
- Ranier's Compounding Laboratory
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1107 Lowry Ave, Jeannette, Pennsylvania 15644-3030
Distribution
- Quantity
- a) 2 vials; b) 1 vial
- Distribution pattern
- Product was distributed within the state of Pennsylvania.
Timeline
- Recall initiated
- 2018-07-25
- FDA classified
- 2018-08-15
- Posted by FDA
- 2018-08-22
- Terminated
- 2022-09-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1086-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.