Why it was recalled
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17
Where it was sold
Nationwide throughout the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0140-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2016
- FDA report date
- Nov 23, 2016
- Quantity
- 18,751 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0140-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75654
- Address
- 100 College Rd W
- Code information
- Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17
- Postal code
- 08540-6604
- Report date
- Nov 23, 2016
- Product type
- Drugs
- Recall number
- D-0140-2017
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 18,751 vials
- Termination date
- Oct 17, 2017
- Reason for recall
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide throughout the USA
- Recall initiation date
- Nov 9, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2016