Drug Enforcement D-0489-2023

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Status

Terminated

Classification

Class II

Report Date

April 12, 2023

Termination Date

December 4, 2023

Product Information

Product description
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.
Product quantity
a) 16,471 vials; b) 43,096 vials
Reason for recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
Azurity Pharmaceuticals, Inc.
Address
841 Woburn St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0489-2023
Event ID
91710
Recall initiation date
February 15, 2023
Center classification date
March 31, 2023
Code info
Lot #23804.034A, 23803.061A, Exp 9/2024
More code info
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