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, 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.
Lot numbers, UPCs & expiration codes
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
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-0141-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2016
- FDA report date
- Nov 23, 2016
- Quantity
- 33,624 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0141-2017, 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 #: 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
- Postal code
- 08540-6604
- Report date
- Nov 23, 2016
- Product type
- Drugs
- Recall number
- D-0141-2017
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 33,624 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, 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.
- Distribution pattern
- Nationwide throughout the USA
- Recall initiation date
- Nov 9, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2016