Why it was recalled
Labeling: Incorrect expiration date.
Product description
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72
Lot numbers, UPCs & expiration codes
Lot#: 12/31/18 0555 21072S, Exp 3/31/2019
Where it was sold
PA
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-0496-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 6, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 100 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0496-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82130
- Address
- 9265 Kirby Dr
- Code information
- Lot#: 12/31/18 0555 21072S, Exp 3/31/2019
- Postal code
- 77054-2520
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0496-2019
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 100 syringes
- Termination date
- Oct 30, 2019
- Reason for recall
- Labeling: Incorrect expiration date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72
- Distribution pattern
- PA
- Recall initiation date
- Feb 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2019