Recalls / Class III
Class IIID-0167-2020
Product
Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDC
- 52536-625
- FDA application
- ANDA206368
- Affected lot / code info
- lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021
Why it was recalled
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Recalling firm
- Firm
- Arbor Pharmaceuticals Inc.
- Manufacturer
- Wilshire Pharmaceuticals
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6 Concourse Pkwy Ste 1800, Atlanta, Georgia 30328-5353
Distribution
- Quantity
- 67934 units
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2019-09-27
- FDA classified
- 2019-10-30
- Posted by FDA
- 2019-11-06
- Terminated
- 2021-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0167-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.