Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, M…
Golden State Medical Supply Inc. · CGMP deviations: tablets with black specks.
- Status
- Ongoing
- City
- Camarillo
- State
- CA
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99614
- Recalling firm
- Golden State Medical Supply Inc.
- Address 1
- 5187 Camino Ruiz
- Postal code
- 93012-8601
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
- Recall number
- D-0771-2026
- Product quantity
- 1200 bottles
- Reason for recall
- CGMP deviations: tablets with black specks.
- Recall initiation date
- 20260807
- Center classification date
- 20260819
- Report date
- 20260826
- Code info
- Lot #: a) GS067429, GS068091, Exp 5/31/2028; b) GS067430, GS068090, Exp 5/31/2028
- Product description
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA
- Harmonized identifiers (openFDA)
- Application number
- ANDA074649
- Brand name
- CARBAMAZEPINE
- Generic name
- CARBAMAZEPINE
- Manufacturer name
- Golden State Medical Supply, Inc.
- Product NDC
- 51407-215
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- CARBAMAZEPINE
- RxCUI
- 308979
- SPL ID
- 4aa97817-1330-a973-e063-6394a90a5ccf
- SPL set ID
- 8a1ce79d-18ea-f30b-e053-2995a90ad1fb
- Package NDC
- 51407-215-01, 51407-215-10
- Original packager product NDC
- 51672-4005
- Nui
- N0000008486, N0000175751, N0000185506, N0000191266, N0000187064, N0000185507, N0000185607
- Pharm class pe
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Pharm class epc
- Mood Stabilizer [EPC]
- Pharm class moa
- Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA]
- UNII
- 33CM23913M