Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials
Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate 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 classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the failure of impurity specifications in an injectable drug.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 176,410 vials of methylprednisolone sodium succinate for injection, USP, 125 mg per vial. The product is a single-dose vial, prescription only, manufactured in India for Sagent Pharmaceuticals in Schaumburg, IL. The recall covers specific lots: AJN601 (Exp. Jun-2018), AJN701, and AJN702 (Exp. Dec-2018).
The recall was initiated because the product failed impurities/degradation specifications, specifically showing high out-of-specification results for an impurity. The agency classification for this recall is Class II.
The product was distributed nationwide in the USA. Patients and healthcare providers should check their inventory for the affected NDC 25021-808-10 and lot numbers listed above. If you have this product, do not use it and contact your healthcare provider or the recalling firm for instructions.
The recalled product
- Product
- methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 176,410
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 #: AJN601
- Exp. Jun-2018
- AJN701
- AJN702
- 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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