Pharmakon Recalls Atropine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 400 units of Atropine Sulfate syringes because the company cannot ensure the products are sterile.
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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are classified as Severe (4). While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of adverse health consequences, aligning with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 400 units of Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is identified by NDC # 45183-0867-71. The recall is being conducted because the company lacks assurance of the sterility of the product.
The affected units were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.
Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 400
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 Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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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