Arbor Pharmaceuticals Inc.: 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

Is my product affected?

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 TESTOSTERONE CYPIONATE

Check against the official notice below — it lists the full affected range.

What happened

Arbor Pharmaceuticals Inc. recalled Testosterone Cypionate Injection manufactured for Wilshire Pharmaceuticals, Inc. The recall involved a labeling mix-up where shipping cartons labeled as single-dose 1 mL vials actually contained shelf cartons labeled as multi-dose 10 mL vials, though the vials inside were the correct single-dose 1 mL vials. The affected product was distributed nationwide in the US, totaling 67,934 units across two lots: lot #23803.002B (expiration 07/2020) and lot #23803.005A (expiration 01/2021).

The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Nationwide in the US Quantity: 67934 units Lot/code info: lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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