Recalls / Class II

Class IID-0051-2016

Product

P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Affected lot / code info

Lot #: 08262015@9, Exp 10/10/2015

Why it was recalled

Lack of assurance of sterility

Recalling firm

Firm

Bedford Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

209 Route 101, N/A, Bedford, New Hampshire 03110-5440

Distribution

Quantity

1 vial

Distribution pattern

NH, MA

Timeline

Recall initiated

2015-09-22

FDA classified

2015-10-15

Posted by FDA

2015-10-21

Terminated

2016-06-08

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0051-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.