Recalls / Class II

Class IID-0104-2016

Product

METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 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

t12312014@6, t12042014@26, t11252014@31, t10302014@35, t10282014@27, t10242014@14, t10032014@26, t10012014@18, t09302014@13, t09222014@22, t09172014@24, t09052014@1, t08132014@16, t07302014@2, t07222014@21, t06302015@5, t06182015@4, t04102015@10, t04062015@2, t03062015@8, t03032015@1, t02102015@22, t01272015@19, t01052015@31, 03312015@14

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 (5mL) syringe, 1 (6mL) syringe, 18 (10mL), 1 (15mL) syringe, 3 (20mL) syringe, 3 (30mL) syringe

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-0104-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.