Dexamethasone Solution Recalled Due to Lack of Sterility Assurance
Specialty Medicine Compounding Pharmacy is recalling Dexamethasone Sodium Phosphate solution because sterility cannot be assured after a related product was found non-sterile.
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 and involves a lack of sterility assurance for a sterile compounded product, which poses a risk of serious health consequences such as infection.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Dexamethasone Sodium Phosphate 4mg/mL solution. The recall covers all sizes of the prescription-only product, including 70 mL bottles. The affected lots were manufactured and distributed between July 1, 2013, and October 19, 2013.
The recall is being conducted because the products were compounded in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled Dexamethasone Sodium Phosphate solution cannot be assured. The agency has classified this recall as Class II.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- 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 (5)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 09112013@1
- 09232013@40
- t09252013@26
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Specialty Medicine 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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