Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk contexts like sterile injectables with sterility assurance failures are categorized as Severe (Score 4), as they pose a serious risk of infection or harm, though not explicitly classified as Class I (Critical) in the source.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 5,086 vials of MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01). The affected product is packaged in 25X1ML per tray (NDC 0703-0031-04) and is available by prescription only. The specific lots involved are Lot # 31327742B with an expiration date of 02/2021 and Lot # 31328408B with an expiration date of 07/2021.
The recall was initiated due to a lack of assurance of sterility. According to the source text, manufacturing areas for these products exceeded acceptance levels for microbial recovery, which led to a lack of sterility assurance for these sterile injectable products.
The product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If the product is found, it should be stopped from use and returned to the supplier or Teva Pharmaceuticals for further instructions.
The recalled product
- Product
- MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Sterile
- Affected units
- 5,086
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 (3)
- Lot # 31327742B
- exp. date 02/2021 Lot # 31328408B
- exp. date 07/2021
Distribution
Part of a larger recall action
This product is one of 15 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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