MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT…
Sagent Pharmaceuticals · Presence of Particulate Matter: Potential for black particulates in the drug product.
- Status
- Ongoing
- City
- Schaumburg
- State
- IL
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 94486
- Recalling firm
- Sagent Pharmaceuticals
- Address 1
- 1901 N Roselle Rd Ste 450
- Address 2
- N/A
- Postal code
- 60195
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0499-2024
- Product quantity
- 14,360 vials
- Reason for recall
- Presence of Particulate Matter: Potential for black particulates in the drug product.
- Recall initiation date
- 20240425
- Center classification date
- 20240515
- Report date
- 20240522
- Code info
- Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
- Product description
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
- Harmonized identifiers (openFDA)
- Application number
- ANDA201835
- Brand name
- METHYLPREDNISOLONE ACETATE
- Generic name
- METHYLPREDNISOLONE ACETATE
- Manufacturer name
- Sagent Pharmaceuticals
- Product NDC
- 25021-820, 25021-821
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUE
- Substance name
- METHYLPREDNISOLONE ACETATE
- RxCUI
- 1358610, 1358617
- SPL ID
- f73618f0-0723-4d8b-8a8d-b9081acb44f9
- SPL set ID
- f98314ea-a4e4-4f78-987b-3e9b45a08bb4
- Package NDC
- 25021-820-05, 25021-820-10, 25021-821-05
- Is original packager
- true
- UNII
- 43502P7F0P