US Compounding Recalls Dex Combo Sterile Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.
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, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports, or high-risk contamination scenarios.
Plain-English summary
US Compounding Inc is recalling 854 vials of Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL), 30 mL Multi-Dose Vials. The product is intended for intramuscular and regional injection and is compounded by US Compounding Pharmacy in Conway, Arkansas.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. The affected lot numbers are 20150705@1, 20151706@49, 20152204@21, and 20152303@26, with expiration dates ranging from September 19, 2015, to December 14, 2015.
The product was distributed nationwide. Patients and healthcare providers should stop using the recalled vials and contact their healthcare provider or pharmacist for further instructions or replacement medication.
The recalled product
- Product
- Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 854
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)
- Lot Numbers: 20150705@1 BUD: 11/2/2015
- 20151706@49 BUD: 12/14/2015
- 20152204@21 BUD: 10/19/2015
- 20152303@26 BUD: 9/19/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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