Why it was recalled
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Product description
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Lot numbers, UPCs & expiration codes
Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
Where it was sold
Distributed to one medical center in Fort Worth, TX.
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-0889-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 20, 2018
- FDA report date
- Jul 4, 2018
- Quantity
- 100 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0889-2018, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 80354
- Address
- 9265 Kirby Dr
- Code information
- Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
- Postal code
- 77054-2520
- Report date
- Jul 4, 2018
- Product type
- Drugs
- Recall number
- D-0889-2018
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 100 syringes
- Termination date
- Apr 3, 2019
- Reason for recall
- Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
- Distribution pattern
- Distributed to one medical center in Fort Worth, TX.
- Recall initiation date
- Jun 20, 2018
- Initial firm notification
- Telephone
- Center classification date
- Jun 25, 2018