Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Product description
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
Lot numbers, UPCs & expiration codes
Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019
Where it was sold
Nationwide in 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-0588-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 48,964 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0588-2018, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79419
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019
- Postal code
- 60195-3194
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0588-2018
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 48,964 vials
- Termination date
- Apr 15, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 5, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 12, 2018