Dexamethasone Injectable and Ophthalmic Products Recalled for Sterility Concerns
Pharmacy Innovations is recalling Dexamethasone injectable and ophthalmic solution products nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
What this means for you
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: FDA Class II recall involving injectable and ophthalmic formulations where sterility assurance cannot be verified due to facility contamination. These are high-risk pharmaceutical products where contamination poses significant risk of harm, though no illnesses or injuries have been reported.
Plain-English summary
Pharmacy Innovations of Erie, Pennsylvania is recalling three Dexamethasone products distributed nationwide: Dexamethasone 16mg/ml (3ml vial) Injectable, Dexamethasone 24mg/ml Injectable, and Dexamethasone-PF 0.1% (1ml dropper) Ophthalmic Solution. All products are prescription-only.
The recall was initiated because FDA inspection revealed insanitary conditions at the manufacturing facility, resulting in a lack of assurance of sterility. Dexamethasone is a corticosteroid used to treat inflammation and immune system conditions. Injectable and ophthalmic formulations must maintain strict sterility standards to prevent serious infections.
Consumers and healthcare providers with affected products should stop using them and consult a healthcare provider or pharmacist. Patients currently taking these medications should not discontinue treatment without medical guidance and should contact their healthcare provider for alternative sources.
The recalled product
- Product
- DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable and Ophthalmic
- Hazard
- contamination
- sterility-failure
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)
- t20221116@36 t20221117@11 t20221108@87
Distribution
Distributed nationwide across the United States.
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