Recalls / Class II

Class IID-0105-2016

Product

METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 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

t12232014@10, t12052014@10, t11182014@16, t11182014@1, t10202014@5, t10132014@2, t09292014@7, t07082015@6, t07082015@30, t06112015@31, t06092015@34, t06052015@27, t06022015@9, t05282015@22, t05262015@8, t05202015@31, t04272015@11, t04132015@19, t03182015@46, t03172015@15, t03052015@22, t01192015@5. t06242015@31, t04022015@16, t02182015@34, t04172015@25, t05132015@30, t06192015@17

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

1 (4mL) syringe, 5 (10mL) syringes, 1 (12mL) syringe, 4 (15mL) syringes, 13 (30mL) syringes, 2 (50mL) syringes, 3 (60mL) 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-0105-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.