The Recall Desk
SevereFDA (Drugs)·D-0012-2018·Announced 2017-10-25

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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

Distributed in 6 states:

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