The Recall Desk
SevereFDA (Drugs)·D-1513-2016·Announced 2016-09-28

Sandoz Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

Sandoz Inc. is recalling specific lots of Ephedrine Sulfate Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

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. According to the rubric, an FDA Class II recall involving a significant hazard such as compromised sterility in an injectable drug warrants a 'Severe' rating (Score 4), particularly given the potential for serious injury from non-sterile medical products.

Plain-English summary

Sandoz Inc. is recalling 32,099 cartons of Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01). The product is packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02) and is available by prescription only. The recall covers specific lots with expiration dates of 08/16 and 09/16.

The recall was initiated because a recent FDA inspection at the manufacturing facility raised concerns that the sterility of the product may be compromised. This lack of assurance of sterility poses a potential risk to patients who receive the injection.

The affected product was distributed nationwide and in Puerto Rico. Healthcare providers and patients should stop using the recalled lots and contact Sandoz Inc. for further instructions or replacements.

The recalled product

Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Manufacturer
Sandoz Inc
Category
Drug — Injectable
Hazard
Affected units
32,099

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 (19)

  • Lot #: 080514
  • 080614
  • 081114
  • 081214
  • 081314
  • 081414
  • 082714
  • 082814
  • 082914
  • Exp 08/16
  • 090214
  • 090314
  • 090814
  • 090914
  • 091014
  • 091114
  • 091214
  • 091514
  • Exp 09/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Sandoz 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 2 products in this recall →

Related recalls

Same manufacturer · Sandoz Inc

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Same hazard · sterility compromise

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