Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason CGMP Deviations
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
What was recalled
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
- Recalling firm
- Teva Pharmaceuticals USA Inc
- NDC code
- 0703-1501-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0988-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Alprostadil recalls
See all
Class II · Moderate risk Completed
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only…
Reason Lack of assurance of sterility.
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