Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 39151…
Zydus Pharmaceuticals (USA) Inc · Failed Impurities/Degradation Specifications.
- Status
- Ongoing
- City
- Pennington
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 100017
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Address 1
- 73 Route 31 N
- Postal code
- 08534-3601
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
- Recall number
- D-0039-2027
- Product quantity
- 70776 vials
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Recall initiation date
- 20261001
- Center classification date
- 20261013
- Report date
- 20261021
- Code info
- Lot #: LB00047A, LB00048A, Exp. Date 03/2028
- Product description
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.
- Harmonized identifiers (openFDA)
- Application number
- ANDA217191
- Brand name
- HYDROCORTISONE SODIUM SUCCINATE
- Generic name
- HYDROCORTISONE SODIUM SUCCINATE
- Manufacturer name
- Zydus Pharmaceuticals USA Inc.
- Product NDC
- 70710-1907
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- HYDROCORTISONE SODIUM SUCCINATE
- RxCUI
- 238755
- SPL ID
- 9e47e808-7310-4c61-ac62-595a5c357123
- SPL set ID
- 37534164-9de5-4bb3-9f87-341dfcf90883
- Package NDC
- 70710-1907-1
- Is original packager
- true
- UNII
- 50LQB69S1Z