Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, ...

FDA Recall #D-0427-2015 — Class II — December 12, 2014

Recall #D-0427-2015 Date: December 12, 2014 Classification: Class II Status: Terminated

Product Description

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Reason for Recall

Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

Recalling Firm

American Specialty Pharmacy — Plano, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

15 vials

Distribution

TX

Code Information

Lot# 10082014@10

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated