Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Product description
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Lot numbers, UPCs & expiration codes
Lot # 31323147B, exp. date 01/2019
Where it was sold
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
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-0244-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 1,362 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0244-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81120
- Address
- 1090 Horsham Rd
- Code information
- Lot # 31323147B, exp. date 01/2019
- Postal code
- 19454-1505
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0244-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 1,362 vials
- Termination date
- Oct 6, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
- Distribution pattern
- Product was distributed throughout the United States, including Hawaii and Puerto Rico.
- Recall initiation date
- Sep 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2018