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 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
Lot numbers, UPCs & expiration codes
Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Where it was sold
Product was distributed nationwide in the US Market
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-0988-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 18, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 3109 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0988-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90239
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
- Postal code
- 07054-1120
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-0988-2022
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 3109 cartons
- Termination date
- Dec 8, 2023
- 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 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
- Distribution pattern
- Product was distributed nationwide in the US Market
- Recall initiation date
- May 18, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2022