RXQ Compounding Recalls Neostigmine Methyl Sulfate Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Neostigmine Methyl Sulfate 1mg/mL Injection Syringes due to a lack of assurance of sterility. The product was distributed nationwide.
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, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated as Severe (4). While specific injury reports are not detailed in the text, the 'lack of assurance of sterility' for an injectable drug represents a significant risk of serious infection, aligning with the Severe category for Class II drug recalls with potential for serious harm.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Neostigmine Methyl Sulfate 1mg/mL Injection Solution Syringes (5 mL per syringe) under FDA recall number D-1688-2019. The recall was initiated because of a lack of assurance of sterility in the product.
The affected product is identified by NDC 70731-0143-05. All lots within the expiration date are included in this recall. The product was distributed nationwide in the United States.
Healthcare providers and patients should stop using the recalled product immediately. Consumers should contact their healthcare provider for guidance on alternative treatments or replacements. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0143-05
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Solution
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding 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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