US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns
US Compounding Inc is recalling 22,627 vials of Methylprednisolone PF (80 mg/mL) because deficient practices may have impacted 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 source text explicitly identifies the agency classification as Class II. Per the rubric, an FDA Class II recall involving a structural defect or significant risk (such as sterility assurance failure in injectable drugs) is classified as Severe (Score 4).
Plain-English summary
US Compounding Inc is recalling 22,627 vials of Methylprednisolone PF (80 mg/mL), 1 mL Single Use Vials, intended for intramuscular and regional injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is 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 expiration dates ranging from September 2015 to January 2016.
Patients who have received this medication should consult their healthcare provider for guidance. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.
- Manufacturer
- US Compounding Inc
- Affected units
- 22,627
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 (8)
- Lot Numbers: 20150806@35 BUD: 12/5/2015
- 20151006@34 BUD: 12/7/2015
- 20152303@42 BUD: 9/19/2015
- 20152704@16 BUD: 10/24/2015
- 20152906@26 BUD: 12/26/2015
- 20153007@19 BUD: 1/26/2016
- 20151703@6 BUD: 9/13/2015
- 20151806@12 BUD: 12/15/2015
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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