Recalls / Class II
Class IID-0003-2017
Product
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
- Affected lot / code info
- 05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016
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
- 455 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-0003-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.