Succinylcholine Chloride Syringes Recalled for Lack of Sterility Assurance
BayCare Central Pharmacy is recalling Succinylcholine Chloride 100 mg/5 mL syringes due to lack of sterility assurance. The affected lot was distributed in Florida.
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: This is an FDA Class II recall for a sterile injectable drug product with a serious quality defect (lack of sterility assurance). Lack of sterility on injectable medications presents a significant risk of serious infection and is classified as Severe under the rubric criterion for FDA Class II recalls involving risk of serious harm.
Plain-English summary
BayCare Integrated Service Center, LLC, doing business as BayCare Central Pharmacy, is recalling Succinylcholine Chloride 100 mg/5 mL (20 mg/mL) in 5 mL syringes due to lack of sterility assurance.
The product is a prescription injectable medication intended for intravenous use. A total of 253 syringes from lot SUCC10020210624 (expiration date 09/22/2021) were distributed in Florida.
Succinylcholine Chloride is a neuromuscular blocking agent used in clinical settings. A lack of sterility assurance on injectable medications raises the risk of serious infection if contaminated product is used.
Consumers and healthcare facilities should stop using the affected product immediately and contact BayCare Central Pharmacy or consult with their healthcare provider regarding appropriate next steps.
The recalled product
- Product
- Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
- Affected units
- 253
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 (1)
- Lot: SUCC10020210624 Exp. 09/22/2021
Distribution
Distributed in 1 state:
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