Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,925 vials of Rocuronium 10 mg/mL syringes because the company cannot guarantee the product is 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile product where sterility assurance is lacking is assigned a score of 4 (Severe) due to the potential for significant injury from non-sterile administration.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 1,925 units of Rocuronium 10 mg/mL, 5 mL syringes (NDC 45183-0955-70). The recall is being conducted because the company lacks assurance of the sterility of the compounded product.
The affected product is a prescription-only sterile compounded medication. The distribution pattern indicates the product was shipped nationwide, with specific mentions of distribution to VA/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 affected syringes and contact Pharmakon Pharmaceuticals or their healthcare provider for instructions on how to return or dispose of the product. No specific lot numbers or expiration dates are provided in the source text, so users should verify the NDC and manufacturer details against their inventory.
The recalled product
- Product
- Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 1,925
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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