SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes 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. The hazard involves a lack of assurance of sterility in a sterile injectable drug, which carries significant risk of infection or serious injury.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of certain lots of Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringes. The recall is being issued due to a potential for leakage in the product, which creates a lack of assurance of sterility.
The affected product is identified by Lot # 20180323@44 with an expiration date of 06/21/2018. A total of 440 syringes were involved in this recall. The product was distributed throughout the United States.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the distributor or the recalling firm, SCA Pharmaceuticals, LLC.
The recalled product
- Product
- Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Affected units
- 440
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 (2)
- Lot # 20180323@44
- Exp 06/21/2018
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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