Vancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns
Well Care Compounding Pharmacy is recalling Vancomycin 50mg/mL ophthalmic solution due to FDA inspection findings of GMP violations that may impact sterility.
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 involves a risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Vancomycin 50mg/mL ophthalmic solution. The product is packaged in 10mL vials and is available by prescription only. The recall affects five specific lots with expiration dates ranging from February 2016 to July 2016.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Ophthalmic Solution
- Affected units
- 869
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 (10)
- Lot #: 01182016:09@28
- Exp. 02/01/2016
- Lot #: 03072016:50@49
- Exp. 03/21/2016
- Lot #: 03232016: 79@7
- Exp. 04/06/2016
- Lot #:03282016:15@10
- Exp. 04/11/2016
- Lot #: 04192016:35@14
- Exp.07/19/2016.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding 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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