Isomeric Pharmacy Recalls Methylprednisolone Acetate/Lidocaine Injection Due to Sterilization Issue
Isomeric Pharmacy Solution, LLC is recalling Methylprednisolone Acetate/Lidocaine HCl Injection because excessive sterilization time may cause difficulty resuspending particles.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary field action for a processing control issue (sterilization time) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Isomeric Pharmacy Solution, LLC is conducting a voluntary field action for Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vials. The recall affects 274 vials from lots 03045 and 03046, which have an expiration date of 10/16.
The recall was initiated because the sterile injectable products were sterilized for too long, which may lead to potential difficulty in resuspending particles. The products were distributed nationwide and in Puerto Rico.
Consumers and healthcare providers should stop using the affected vials and contact Isomeric Pharmacy Solution, LLC for further instructions or a return.
The recalled product
- Product
- Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
- Manufacturer
- Isomeric Pharmacy Solution, LLC
- Category
- Drug — Injectable Sterile
- Affected units
- 274
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 (2)
- Lots# 03045 and 03046
- Exp. 10/16
Distribution
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