Teva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of 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, which corresponds to a Severe rating under the rubric, particularly given the risk of serious injury from non-sterile injectable medication.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vials. The recall is being conducted due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # 31327989B with an expiration date of 04/2021. The product was distributed nationwide. The recall involves 7,564 cartons, with each carton containing one multiple dose vial.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions. Consumers should not use the product and should return it to the pharmacy or contact the manufacturer for a refund.
The recalled product
- Product
- Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Steroid
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 # 31327989B
- exp. date 04/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teva Pharmaceuticals USA 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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