Injectable midazolam HCl recalled due to sterility assurance failure
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II drug recall for an injectable medication where sterility cannot be assured. The source does not report any confirmed contamination, illnesses, injuries, or deaths. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection nationwide. The initial recall affects 1,508 bags, with an expanded recall affecting an additional 1,015 bags. The product is distributed throughout the USA.
The recall was issued because the manufacturer cannot assure the sterility of the affected batches. Midazolam is a sedative administered by injection, and loss of sterility assurance could permit microbial contamination, creating a risk of serious infection to patients who receive the affected medication.
Healthcare facilities, hospitals, and medical providers who received the affected lots should stop using the product immediately. Affected lot numbers include 1223044958, 1223045436, 1223046132, 1223046385, 1223048807, and 1223049030 (initial recall), and 1223049328, 1223048948, 1223048631, and 1223050389 (expanded recall), with expiration dates ranging from November 2023 through June 2024. Patients should consult their healthcare provider if they have received an affected dose and have questions or concerns.
The recalled product
- Product
- Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Hazard
- contamination
- infection-risk
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 (13)
- Lot#: 1223044958 Exp 11/10/23
- 1223045436 Exp 11/30/23
- 1223046132 Exp 12/28/23
- 1223046385 Exp 01/06/24
- 1223048807 Exp 04/17/24
- 1223049030 Exp 04/26/24 Expanded Recall lots: 1223049328
- Exp 05/10/2024
- 1223048948
- Exp 04/21/2024
- 1223048631
- Exp 04/10/2024
- 1223050389
- Exp 06/21/2024.
Distribution
Distributed nationwide across the United States.
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