Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
Why it was recalled
Lack of Assurance of Sterility
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Lot #: 1223048530, Exp 11/22/23; 1223048692 Exp 11/29/23; 1223048739 EXP 11/30/23; 1223048826 Exp 12/05/23; 1223048963 Exp 12/08/23; 1223048964 EXP 12/11/23; 1223049111 Exp 12/15/23; 1223049128 Exp12/19/23; 1223049210 EXP 12/21/23; 1223049234 Exp 12/22/23; 1223049257 Exp 12/22/23; 1223049322 Exp 12/27/23; 1223049416 Exp 12/28/23; 1223049528 Exp 01/03/24; 1223049559 Exp 01/04/24; 1223049614 Exp 01/05/24; 1223049632 Exp 01/08/24; 1223049725 Exp 01/11/24; 1223049792 Exp 01/15/24; 1223049793 Exp 01/15/24; 1223049905 Exp 01/19/24; 1223050029 Exp 1/24/24; 1223050061 Exp 01/25/24; 1223050179 Exp 01/29/24
Recall status
Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.
Where it was distributed
Nationwide in the USA
Recall record
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product type
- Drugs
- Recall number
- D-0405-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Windsor, CT
- Recall initiated
- 2023-11-09
- Terminated
- 2024-08-27
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall D-0405-2024 · Source: openFDA enforcement.