The Recall Desk
SevereFDA (Drugs)·D-0588-2018·Announced 2018-03-21

Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.

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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), as the rule states that if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4, and Class II generally maps to Severe in the absence of specific Class I criteria or explicit 'no injury' theoretical hazard language that would cap it at 3. Given the lack of explicit 'no injury' language and the presence of a Class II designation for a drug impurity issue, 4 is the appropriate score.

Plain-English summary

Sagent Pharmaceuticals Inc is recalling 48,964 vials of methylprednisolone sodium succinate for injection, USP, 1 gram per vial. The product is a single-dose vial, prescription only, manufactured in India for Sagent Pharmaceuticals in Schaumburg, IL. The recall is due to failed impurities and degradation specifications, specifically high out-of-specification results for an impurity.

The affected product is identified by NDC 25021-810-30. The recall includes lots AJP701 and AJP702 with an expiration date of December 2018, lot AJP601 with an expiration date of July 2018, and lot AJP703 with an expiration date of August 2019. The product was distributed nationwide in the USA.

Healthcare providers and patients should stop using the affected vials and contact Sagent Pharmaceuticals or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
Manufacturer
Sagent Pharmaceuticals Inc
Category
Drug — Injectable Steroid
Hazard
Affected units
48,964

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 (7)

  • Lot #: AJP701
  • AJP702
  • Exp. Dec-2018
  • AJP601
  • Exp. Jul-2018
  • AJP703
  • Exp. Aug-2019

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.

See all 3 products in this recall →

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Same hazard · impurity

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