US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns
US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL 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 and involves a lack of sterility assurance in an injectable medication, which poses a risk of serious adverse health consequences such as infection.
Plain-English summary
US Compounding Inc is voluntarily recalling 3,629 vials of Methylprednisolone (100 mg/mL) 10 mL Multi-Dose Vials. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall affects specific lots with expiration dates ranging from September 22, 2015, to December 20, 2015.
The recall is being conducted due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on the sterility assurance of the sterile preparations. This is classified as an FDA Class II recall.
Healthcare providers and patients should discontinue use of the affected vials and contact their pharmacist or the recalling firm for further instructions. The affected product is prescription-only and intended for intramuscular and regional injection.
The recalled product
- Product
- MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
- Manufacturer
- US Compounding Inc
- Affected units
- 3,629
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)
- Lot Numbers: 20150806@41 BUD: 12/5/2015
- 20151205@67 BUD: 11/8/2015
- 20151504@24 BUD: 10/12/2015
- 20152306@30 BUD: 12/20/2015
- 20152603@27 BUD: 9/22/2015
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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