Recalls / Class II
Class IID-0305-2021
Product
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.
- Brand name
- Phenylephrine Hydrochloride
- Generic name
- Phenylephrine Hydrochloride
- Active ingredient
- Phenylephrine Hydrochloride
- Route
- Intravenous
- NDC
- 25021-315
- FDA application
- ANDA209967
- Affected lot / code info
- Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
Why it was recalled
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Manufacturer
- Sagent Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 450, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 3716 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2021-03-11
- FDA classified
- 2021-03-17
- Posted by FDA
- 2021-03-24
- Terminated
- 2022-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0305-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.