Why it was recalled
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Product description
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Lot numbers, UPCs & expiration codes
Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
Where it was sold
Nationwide in the USA 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-0305-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2021
- FDA report date
- Mar 24, 2021
- Quantity
- 3716 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0305-2021, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87492
- Address
- 1901 N Roselle Rd Ste 450
- Code information
- Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
- Postal code
- 60195-3194
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0305-2021
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 3716 cartons
- Termination date
- Dec 28, 2022
- Reason for recall
- Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 11, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 17, 2021