FDA Recalls Compounded Acetyl-L-Cysteine Ophthalmic Solution Due to Processing Controls
Compounded Solutions in Pharmacy is recalling 20% Acetyl-L-Cysteine Ophthalmic Solutions because of a lack of processing controls. The product was dispensed to patients in 3ml dropper bottles.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses or injuries, and the hazard is a lack of processing controls, which fits the criteria for a High severity score where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottles. The recalling firm is Compounded Solutions in Pharmacy. The recall is classified as Class II by the agency.
The reason for the recall is a lack of processing controls. The source text does not specify the exact nature of the processing failure or any specific contaminants. The affected lots include 07172019@39 (expiration 8/31/19, Rx # 215042), 06192019@28 (expiration 7/03/19, Rx # 219335), and 06052019@8 (expiration 6/19/19, Rx # 222826).
The product was dispensed to patients. The source text does not specify the geographic distribution or the number of patients affected. Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
- Manufacturer
- Compounded Solutions in Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
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 (4)
- Lots: 07172019@39 exp: 8/31/19
- Rx # 215042 06192019@28 exp: 7/03/19
- Rx # 219335 06052019@8 exp: 6/19/19
- Rx # 222826
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Compounded Solutions in Pharmacy 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.
See all 3 products in this recall →Related recalls
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