December 2014 FDA Recall Drug by American Specialty Pharmacy
D-0427-2015 - Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

This Class II drug recall was voluntarily initiated by American Specialty Pharmacy on December 12, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; preservative may not have dissolved completely or precipitated out of product. The product was distributed in TX and the recall is currently terminated.

Recall Number: D-0427-2015

Reason for Recall
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Initiated
12-12-2014
Reported
04-01-2015
Quantity
15 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70013
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Specialty Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-23-2016
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Batch or Lot Expiration Information

Lot# 10082014@10