SCA Pharmaceuticals Recalls Diltiazem HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury risks or hospitalization reports, though no specific injuries are detailed in the source text.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of certain lots of Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bags. The recall involves 2,869 bags of the sterile admixture.
The recall is being issued due to a lack of assurance of sterility resulting from a potential for leakage in the product packaging. The affected product was distributed throughout the United States.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor.
The recalled product
- Product
- Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixture
- Affected units
- 2,869
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 (12)
- Lot # 1218001315
- 1218001316
- 1218001349
- 1218001416
- 1218001510
- 1218001682
- 1218001683
- 1218001684
- 1218001721
- 1218001763
- 1218001764
- Exp 07/26/2018-08/27/2018
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by SCA Pharmaceuticals, LLC 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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