Why it was recalled
Lack of assurance of sterility: Product bags leaking at seam.
Product description
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
Lot numbers, UPCs & expiration codes
LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17
Where it was sold
Nationwide in the USA
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-0872-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2017
- FDA report date
- Jun 7, 2017
- Quantity
- 118 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0872-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77314
- Address
- 8821 Knoedl Ct
- Code information
- LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17
- Postal code
- 72205-4600
- Report date
- Jun 7, 2017
- Product type
- Drugs
- Recall number
- D-0872-2017
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 118 bags
- Termination date
- Mar 29, 2018
- Reason for recall
- Lack of assurance of sterility: Product bags leaking at seam.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 18, 2017
- Initial firm notification
- Letter
- Center classification date
- May 31, 2017