Wise Pharmacy Recalls Dexamethasone Sodium Phosphate Injection Due to Processing Controls
Wise Pharmacy is recalling 27 vials of Dexamethasone Sodium Phosphate Injection because of 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to processing controls rather than a specific high-risk pathogen or structural defect.
Plain-English summary
Wise Pharmacy, located in Littleton, Colorado, is recalling 27 vials of Dexamethasone Sodium Phosphate PF 24 mg/mL Injection. The recall is being conducted due to a lack of processing controls. The affected product is a single-use, 1 mL vial intended for prescription use only.
The recalled lots are identified as 5506N with an expiration date of 9/21/2019, and 7180N with an expiration date of 12/29/2019. The product was distributed in Colorado, Texas, and Wyoming.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Manufacturer
- Wise Pharmacy
- Category
- Drug — Injection
- Hazard
- Affected units
- 27
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 #: 5506N
- Exp 9/21/2019
- 7180N
- Exp 12/29/2019
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.
See all 11 products in this recall →Related recalls
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