Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials
Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.
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 are assigned a severity score of 4 (Severe), particularly when involving significant quality failures like impurities in injectable drugs.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 205,370 vials of methylprednisolone sodium succinate for injection, USP, 40 mg per vial. The product is a single-dose vial, prescription only, manufactured in India for Sagent Pharmaceuticals in Schaumburg, IL. The affected lots are AJM601 (Exp. Jul-2018), AJM701, and AJM702 (Exp. Dec-2018). The NDC number is 25021-807-05.
The recall was initiated because of failed impurities/degradation specifications, specifically high out-of-specification results for an impurity. The agency classified this as a Class II recall.
The product was distributed nationwide in the USA. Healthcare providers and patients should stop using the affected vials and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 205,370
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 (5)
- Lot #: AJM601
- Exp. Jul-2018
- AJM701
- AJM702
- Exp. Dec-2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sagent Pharmaceuticals Inc 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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