Ranier's Compounding Laboratory Recalls Acetylcysteine 10% Ophthalmic Solution
Ranier's Compounding Laboratory is recalling Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in 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, which corresponds to a Severe severity score per the rubric.
Plain-English summary
Ranier's Compounding Laboratory is recalling Acetylcysteine 10% Ophthalmic Solution, 10 mL droptainer, 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. All lots with expiry dates are included in this recall.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Acetylcysteine 10% Oph Solution, 10 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
- 1
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 with 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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