Why it was recalled
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Product description
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
Lot numbers, UPCs & expiration codes
Lot #s: 04282015@9, BUD 10/25/2015; 04172015@15, BUD 10/14/2015; 04022015@10, BUD 9/1/2015
Where it was sold
Oklahoma
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-1297-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2015
- FDA report date
- Aug 12, 2015
- Quantity
- 378 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Apothecary Shoppe LLC
Original FDA data
Every field from FDA enforcement report D-1297-2015, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 71618
- Address
- 6136 E 51st St
- Code information
- Lot #s: 04282015@9, BUD 10/25/2015; 04172015@15, BUD 10/14/2015; 04022015@10, BUD 9/1/2015
- Postal code
- 74135-7704
- Report date
- Aug 12, 2015
- Product type
- Drugs
- Recall number
- D-1297-2015
- Classification
- Class II
- Recalling firm
- The Apothecary Shoppe LLC
- Product quantity
- 378 mL
- Termination date
- Feb 17, 2017
- Reason for recall
- Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
- Distribution pattern
- Oklahoma
- Recall initiation date
- Jun 26, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2015