SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
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: The recall involves a risk-of-harm product (sterile medication) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of certain lots of Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bags. The recall is being initiated due to a potential for leakage in the sterile admixtures, which raises concerns regarding the assurance of sterility.
The affected product was distributed throughout the United States. The recall involves 1,397 bags from specific lots with expiration dates ranging from June 19, 2018, to July 3, 2018. The specific lot numbers affected are 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, and 1218001210.
Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixture
- Affected units
- 1,397
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 (17)
- Lot # 1218000677
- 1218000947
- 1218000982
- 1218001018
- 1218001029
- 1218001059
- 1218001060
- 1218001078
- 1218001079
- 1218001171
- 1218001172
- 1218001192
- 1218001193
- 1218001207
- 1218001209
- 1218001210
- Exp 06/19/2018-07/03/2018
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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