Ranier's Compounding Laboratory Recalls Atropine 0.01% Opth Solution
Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution due to a lack of assurance of sterility. The product was distributed within Pennsylvania.
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 or property damage reports, or in this case, a critical sterility failure for a sterile product, align with the Severe classification criteria.
Plain-English summary
Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution, 5 mL droptainer, prescription only. The recall is being conducted because 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 covers all lots within expiry.
Consumers should stop using the product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
- Manufacturer
- Ranier's Compounding Laboratory
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 5
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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