Ace Surgical Recalls Mislabeled Succinylcholine Vials Due to Expiration Date Error
Ace Surgical Supply Co. is recalling 25 vials of Succinylcholine 20 mg/mL due to an incorrect expiration date on the outer poly bag labeling.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ace Surgical Supply Co., Inc. is recalling 25 vials of Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials. The recall is limited to Lot # 64340EV, with an expiration date of 07/2018 and ACE ITEM # 1671018. The product is distributed throughout the United States.
The recall was initiated because of a labeling error where the expiration date on the outer poly bag was incorrect. This mislabeling could lead to the use of expired medication or confusion regarding the product's shelf life.
Healthcare providers and facilities that have received this specific lot of Succinylcholine should check their inventory for Lot # 64340EV. If the product is found, it should be removed from use and returned to the distributor or the recalling firm, Ace Surgical Supply Co., Inc.
The recalled product
- Product
- Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
- Manufacturer
- Ace Surgical Supply Co., Inc.
- Category
- Drug — Injectable
- Hazard
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 # 64340EV
- exp 07/2018 ACE ITEM # 1671018
Distribution
Distribution scope not specified by the agency.
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