Recalls / Class II
Class IID-0065-2016
Product
CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Affected lot / code info
- t12292014@35, t12192014@15, t12162014@29, t10232014@24, t09162014@29, t09032014@6, t07252014@16, t07142015@6, t07022015@8, t06152015@32, t05272015@33, t04282015@11, t04162015@34, t04092015@8, t04022015@30, t02262015@24, t02032015@21, and t01232015@10
Why it was recalled
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Recalling firm
- Firm
- JD & SN Inc., dba Moses Lake Professional Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1555 Pilgrim St, N/A, Moses Lake, Washington 98837-4623
Distribution
- Quantity
- 9 (5mL) vials, 2 (6mL) vials, 8 (8mL) vials, 2 (10mL) vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-24
- FDA classified
- 2015-10-27
- Posted by FDA
- 2015-11-04
- Terminated
- 2016-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0065-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.