Wise Pharmacy Recalls Acetylcysteine Otic Drops Due to Processing Controls
Wise Pharmacy is recalling Acetylcysteine 2% Otic Drops due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
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 FDA classified this recall as Class II, which corresponds to a Severe severity score under the rubric for drug recalls.
Plain-English summary
Wise Pharmacy, located in Littleton, Colorado, is recalling Acetylcysteine 2% Otic Drop, 15 mL bottles. The recall was initiated because of a lack of processing controls. The affected product is prescription-only and requires refrigeration.
The specific lot number is 7131N, with an expiration date of July 11, 2019. The product was distributed in Colorado, Texas, and Wyoming. The FDA has classified this recall as Class II.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Manufacturer
- Wise Pharmacy
- Category
- Drug — Compounded Prescription
- 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 (2)
- Lot #: 7131N
- Exp 7/11/19
Distribution
Part of a larger recall action
This product is one of 11 recalled by Wise 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.
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