SCA Pharmaceuticals Recalls Hydromorphone Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 428 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential sterility issues in injectable medications.
Plain-English summary
SCA Pharmaceuticals is recalling 428 single-dose syringes of HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection. The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit.
The affected product is a Schedule II prescription-only medication distributed to hospitals nationwide. The specific lots involved are 1220023220 (Best Use Date 1/31/2021), 1220023337 (Best Use Date 2/2/2021), and 1220023443 (Best Use Date 2/22/2021).
Healthcare facilities and consumers should check their inventory for these specific lot numbers and discontinue use of the affected syringes. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 428
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 (5)
- Lot # 1220023220
- BUD 1/31/2021
- 1220023337
- BUD 2/2/2021 & 1220023443
- BUD 2/22/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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.
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