Testosterone Cypionate Injection recall: CGMP Deviations
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.
Why was Testosterone Cypionate Injection recalled?
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #23804.034A, 23803.061A, Exp 9/2024
- Product
- 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.
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Quantity
- a) 16,471 vials; b) 43,096 vials
- Distribution
- US Nationwide
- Recall date
- April 12, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)