US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe).
Plain-English summary
US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL (7 mg/mL), a prescription-only multi-dose vial intended for intramuscular and regional injection. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide.
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 recall covers specific lot numbers with best-use dates ranging from September 2015 to December 2015.
Patients who have received this medication should consult their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 19,494
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 (11)
- Lot Numbers: 20150104@4 BUD: 9/27/2015
- 20150105@1 BUD: 10/27/2015
- 20150107@25 BUD: 12/27/2015
- 20150306@44 BUD: 11/29/2015
- 20150704@49 BUD: 10/3/2015
- 20150705@5 BUD: 11/1/2015
- 20151106@17 BUD: 12/7/2015
- 20151305@5 BUD: 11/8/2015
- 20151806@19 BUD: 12/13/2015
- 20152005@29 BUD: 11/15/2015
- 20152205@7 BUD: 11/16/2015
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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