SCA Pharmaceuticals Recalls Hydrocodone Injectable Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 87 bags of Hydromorphone HCL injectable solution because the bags are leaking at the seam, compromising sterility.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or property damage (such as sterility failure in an injectable drug) are rated as Severe (4).
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 87 bags of Hydromorphone HCL in 0.9% Sodium Chloride injectable solution. The product is a 100 mL single-dose container bag containing a total dose of 20 mg of Hydromorphone HCL. The recall is due to a lack of assurance of sterility, as the product bags were found to be leaking at the seam.
The affected product is identified by NDC 70004-0300-55 and includes lot numbers 20170505@23 and 20170505@28, with a use-by date of August 3, 2017. The product was distributed nationwide in the United States. No specific illnesses or injuries have been reported in the source text.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Solution
- Affected units
- 87
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 (3)
- LOT # 20170505@23
- 20170505@28
- Use By: 08/03/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 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 failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22