Ranier's Compounding Laboratory Recalls Dehydrated Alcohol Solution Due to Sterility Concerns
Ranier's Compounding Laboratory is recalling Dehydrated Alcohol Solution vials because practices at the firm may call into question the sterility of the products.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility for a medical product, which aligns with the 'Severe' criteria for significant risk or Class II classifications with potential for serious harm.
Plain-English summary
Ranier's Compounding Laboratory is recalling Dehydrated Alcohol Solution, which is packaged in 1 mL and 3 mL vials and available by prescription only. The recall is due to a lack of assurance of sterility, as practices at the firm may call into question the sterility of products intended to be sterile.
The affected product was distributed within the state of Pennsylvania. The recall includes all lots within expiry. No specific lot numbers or dates are provided in the source text.
Consumers with this product should contact their healthcare provider or pharmacist for instructions on how to proceed. The source text does not specify a return address or contact number for the recall.
The recalled product
- Product
- Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
- Manufacturer
- Ranier's Compounding Laboratory
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 in 1 state:
Part of a larger recall action
This product is one of 15 recalled by Ranier's Compounding Laboratory 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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