Why it was recalled
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Product description
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
Lot numbers, UPCs & expiration codes
Lot #: 497940, Exp 9/6/2013
Where it was sold
Nationwide
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-1023-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 85 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- University Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-1023-2013, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66206
- Address
- 1875 3rd Avenue
- Code information
- Lot #: 497940, Exp 9/6/2013
- Postal code
- 92101
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-1023-2013
- Classification
- Class II
- Recalling firm
- University Compounding Pharmacy
- Product quantity
- 85 mL
- Termination date
- Jan 21, 2014
- Reason for recall
- Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 6, 2013
- Initial firm notification
- Press Release
- Center classification date
- Sep 12, 2013