US Compounding Recalls Methylprednisolone/Lidocaine Vials Due to Sterility Concerns
US Compounding Inc is recalling 11,363 vials of Methylprednisolone/Lidocaine 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, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
US Compounding Inc is recalling 11,363 vials of Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vials. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall is initiated due to deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates.
The affected product is a prescription-only medication intended for intramuscular and regional injection. The recall covers specific lot numbers with expiration dates ranging from September 2015 to January 2016. The firm is recalling all sterile preparations that are within expiry due to the lack of assurance of sterility.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. Patients who have already received the medication should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07
- Manufacturer
- US Compounding Inc
- Affected units
- 11,363
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: 20150707@31 BUD: 1/3/2016
- 20150707@36 BUD: 1/3/2016
- 20151106@19 BUD: 12/8/2015
- 20151604@24 BUD: 10/13/2015
- 20151606@20 BUD: 12/13/2015
- 20151805@60 BUD: 11/14/2015
- 20152105@35 BUD: 11/17/2015
- 20153103@13 BUD: 9/27/2015
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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