PharMEDium Recalls Succinylcholine Chloride Vials Due to Sterility Concerns
PharMEDium Services is recalling specific vials of Succinylcholine Chloride because a portion of the batch was compounded outside of validated process media, raising sterility concerns.
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. According to the rubric, an FDA Class II recall involving a significant risk of harm (such as sterility failure in an injectable drug) corresponds to a severity score of 4 (Severe), particularly when structural or process validation failures are involved.
Plain-English summary
PharMEDium Services, LLC is recalling 1,550 units of Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials (NDC 61553-0364-65). The affected product is identified by Lot # 162790012M and has an expiration date of 1/3/2017. The recall is being conducted nationwide.
The recall was initiated due to a lack of assurance of sterility. According to the source text, a portion of the batch quantity was compounded outside of the firm's process media validation. This deviation from validated processes raises concerns regarding the sterility of the medication.
Healthcare providers and patients should check their inventory for the specific lot number and expiration date listed above. If the product matches these details, it should be discontinued and returned to the manufacturer or disposed of according to local regulations. No specific instructions for consumer action are provided in the source text beyond the identification of the affected units.
The recalled product
- Product
- Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 1,550
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 #: 162790012M
- Exp. 1/3/2017
Distribution
Distributed nationwide across the United States.
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