Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns
Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials 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 and involves a lack of assurance of sterility, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials. The recall involves 33,624 vials distributed nationwide throughout the USA. The specific lots affected are 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215 (Exp 07/17), 2092315, 2093015 (Exp 09/17), 2100115 (Exp 10/17), and 2120115, 2120215 (Exp 12/17).
The recall was initiated because a recent FDA inspection at the manufacturing firm raised concerns that the product's sterility may be compromised. This is classified as an FDA Class II recall.
Healthcare providers and pharmacies should stop using the affected lots and contact Sandoz Inc. for instructions on returning the product. Patients should consult their healthcare provider if they have questions regarding the use of this medication.
The recalled product
- Product
- L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
- Manufacturer
- Sandoz Inc
- Category
- Drug — Injectable Medication
- Affected units
- 33,624
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 (17)
- Lot #: 2070915
- 2071015
- 2071415
- 2071515
- 2071615
- 2071715
- 2072115
- 2072215
- Exp 07/17
- 2092315
- 2093015
- Exp 09/17
- 2100115
- Exp 10/17
- 2120115
- 2120215
- Exp 12/17
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.
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