Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manuf…
Hikma Pharmaceuticals USA INC. · Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Status
- Ongoing
- City
- Columbus
- State
- OH
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99711
- Recalling firm
- Hikma Pharmaceuticals USA INC.
- Address 1
- 1809 Wilson Rd
- Address 2
- N/A
- Postal code
- 43228-9579
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
- Recall number
- D-0831-2026
- Product quantity
- a) 25,970 bottles; b) 2,384 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Recall initiation date
- 20260824
- Center classification date
- 20260903
- Report date
- 20260902
- Code info
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Product description
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
- Harmonized identifiers (openFDA)
- Application number
- ANDA077900
- Brand name
- RAMIPRIL
- Generic name
- RAMIPRIL
- Manufacturer name
- Exelan Pharmaceuticals, Inc.
- Product NDC
- 76282-670, 76282-671, 76282-672, 76282-673
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- RAMIPRIL
- RxCUI
- 198188, 198189, 261962, 845488
- SPL ID
- 37481fc5-771f-4dc7-aa06-6913ab75d485
- SPL set ID
- 1e1dfacf-b831-4743-a874-9a5e5ef8a120
- Package NDC
- 76282-670-01, 76282-671-01, 76282-671-05, 76282-672-01, 76282-672-05, 76282-673-01, 76282-673-05
- Is original packager
- true
- Upc
- 0376282670010, 0376282672014, 0376282673011
- Nui
- N0000175562, N0000000181
- Pharm class epc
- Angiotensin Converting Enzyme Inhibitor [EPC]
- Pharm class moa
- Angiotensin-converting Enzyme Inhibitors [MoA]
- UNII
- L35JN3I7SJ