RXQ Compounding Recalls Methylprednisolone Acetate Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling 945 vials of methylprednisolone acetate injection because autoclave parameters were incorrect, raising concerns about product sterility.
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 assurance of sterility in an injectable drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
RXQ Compounding LLC is recalling 945 vials of methylprednisolone acetate 40 mg/mL injection suspension, 10 mL vials (NDC: 70731-0936-10). The recall was initiated because autoclave parameters were not correct for one of two autoclaves used to sterilize the product, resulting in a lack of assurance of sterility.
The affected product, Lot 04252017@1 with an expiration date of 5/9/2018, was distributed to Texas, Louisiana, Pennsylvania, Massachusetts, Florida, and Ohio. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Steroid
- Affected units
- 945
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)
- Lot: 04252017@1
- exp 5/9/2018
Distribution
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