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
Product description
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
Lot numbers, UPCs & expiration codes
lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0167-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 27, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 67934 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Arbor Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0167-2020, exactly as published.
Show all FDA fields
- City
- Atlanta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 83959
- Address
- 6 Concourse Pkwy Ste 1800
- Code information
- lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021
- Postal code
- 30328-5353
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0167-2020
- Classification
- Class III
- Recalling firm
- Arbor Pharmaceuticals Inc.
- Product quantity
- 67934 units
- Termination date
- Feb 2, 2021
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Sep 27, 2019
- Initial firm notification
- Center classification date
- Oct 30, 2019