Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:…
Cipla USA, Inc. · Failed Impurities/Degradation Specifications
- Status
- Ongoing
- City
- Warren
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99930
- Recalling firm
- Cipla USA, Inc.
- Address 1
- 10 Independence Blvd
- Address 2
- N/A
- Postal code
- 07059-2730
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- USA Nationwide.
- Recall number
- D-0014-2027
- Product quantity
- N/A
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation date
- 20260918
- Center classification date
- 20261006
- Report date
- 20261014
- Code info
- Lot#: 5KA0405, Exp 12/31/2026.
- Product description
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
- Harmonized identifiers (openFDA)
- Application number
- ANDA211881
- Brand name
- FOSFOMYCIN TROMETHAMINE
- Generic name
- FOSFOMYCIN TROMETHAMINE
- Manufacturer name
- Cipla USA Inc.
- Product NDC
- 69097-579
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- FOSFOMYCIN TROMETHAMINE
- RxCUI
- 808917
- SPL ID
- 80c866f4-c984-469e-b2a5-5c23f29b9750
- SPL set ID
- d101b5d8-bffc-4ee6-b93b-4589fcb8750d
- Package NDC
- 69097-579-67
- Is original packager
- true
- UNII
- 7FXW6U30GY