SCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 130 bags of fentanyl citrate injection due to a lack of assurance of sterility caused by potential leaks in the sodium chloride bags used.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which carries a risk of significant injury or infection.
Plain-English summary
SCA Pharmaceuticals is recalling 130 bags of fentanyl (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, 100 mL Single Dose Container bags. The product is identified by NDC 70004-0202-32, Lot 20170707@27, and a best-use-by date of 10/5/2017. The recall was initiated because the product was made with recalled 0.9% sodium chloride bags that have the potential to leak, resulting in a lack of assurance of sterility.
The affected product was distributed nationwide in the USA. This is a prescription-only medication. The source text does not specify specific healthcare facilities or patients affected, nor does it report any illnesses or injuries associated with the use of this product.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals at (877) 550-5059 for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 130
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 20170707@27
- BUD: 10/5/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by SCA Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals
See all →- HighSCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
- ModerateFDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
- ModerateFentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
- ModerateNorepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations
FDA (Drugs) · 2022-05-11
- ModerateDrug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29