Why it was recalled
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Product description
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Lot numbers, UPCs & expiration codes
Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16
Where it was sold
Nationwide and Puerto Rico
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-1514-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2016
- FDA report date
- Sep 28, 2016
- Quantity
- a) 1,584 cartons; b) 62,170 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-1514-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75032
- Address
- 100 College Rd W
- Code information
- Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16
- Postal code
- 08540-6604
- Report date
- Sep 28, 2016
- Product type
- Drugs
- Recall number
- D-1514-2016
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- a) 1,584 cartons; b) 62,170 vials
- Termination date
- Jul 12, 2017
- Reason for recall
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 24, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 19, 2016