Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:…
Safecor Health, LLC · Failed Stability Specifications
- Status
- Ongoing
- City
- Woburn
- State
- MA
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99654
- Recalling firm
- Safecor Health, LLC
- Address 1
- 317 New Boston St
- Address 2
- N/A
- Postal code
- 01801-6231
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
- Recall number
- D-0845-2026
- Product quantity
- N/A
- Reason for recall
- Failed Stability Specifications
- Recall initiation date
- 20260813
- Center classification date
- 20260914
- Report date
- 20260923
- Code info
- Lot#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026
- Product description
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04