Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Safecor Health, LLC
- Product
- Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
- Reason / hazard
- Failed Stability Specifications
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA.
- Recall initiated
- 2026-08-13
- Code info
- Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Woburn
- State
- MA
- Country
- United States
- Event id
- 99654
Free daily digest + "My products" watchlist