The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0140-2017·Announced 2016-11-23

Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

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 source text explicitly identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), and the rule states that if the agency's classification is FDA Class I or II, the score must not be lower than 4.

Plain-English summary

Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vials. The recall involves 18,751 vials distributed nationwide throughout the USA. The affected lots are 2081915, 2082015, 2082115, 2082815, 2083115 (Exp 08/17) and 2090115 (Exp 09/17).

The recall was initiated because a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. This is classified as an FDA Class II recall.

Healthcare providers and patients should stop using the affected vials and contact Sandoz Inc. for further instructions or returns.

The recalled product

Product
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Manufacturer
Sandoz Inc
Category
Drug — Injectable
Hazard
Affected units
18,751

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 (8)

  • Lot #: 2081915
  • 2082015
  • 2082115
  • 2082815
  • 2083115
  • Exp 08/17
  • 2090115
  • Exp 09/17

Distribution

Distributed nationwide across the United States.

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 →

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