Recalls / Class II
Class IID-0004-2017
Product
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
- Affected lot / code info
- 07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016
Why it was recalled
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Recalling firm
- Firm
- The Apothecary Shoppe LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6136 E 51st St, N/A, Tulsa, Oklahoma 74135-7704
Distribution
- Quantity
- 247.5 mL total volume
- Distribution pattern
- Oklahoma
Timeline
- Recall initiated
- 2016-09-12
- FDA classified
- 2016-10-04
- Posted by FDA
- 2016-10-12
- Terminated
- 2018-01-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0004-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.