Recalls / Class II

Class IID-0100-2016

Product

HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 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

t12182014@7, t12052014@12, t10312014@21, t10102014@21, t10072014@6, t09172014@30, t09152014@11, t08132014@13, t08112014@28, t07282014@28, t07282014@16, t07012015@7, t06302015@31, t06222015@17, t06112015@14, t06022015@17, t05182015@24, t05152015@19, t05072015@9, t04272015@19, t04232015@22, t04212015@16, t04162015@21, t04092015@2, t04022015@27, t03162015@16, t03052015@25, t03022015@13, t02272015@22, t02202015@23, t02172015@8, t02132015@19, 08202014@12, 05042015@11; t02062015@29, t03312015@5, t06052015@3, t06172015@47, t06292015@13, and t10232014@22, t07242014@6

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

3 (4mL) syringes, 4 (5mL) syringes, 1 (6mL) syringe, 13 (10mL) syringes, 1 (16mL) syringe, 1 (18mL) syringe, 14 (20mL) syringes, 2 (22mL) syringes

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-0100-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.