Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Stability & shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency.
560 FDA drug recalls with this cause, newest first.
These recalls involve products whose stability data no longer supports the expiry date on the label, or that failed a stability test before that date. A medicine that loses potency early does not just stop working as well; it can also change chemically into something FDA never approved. The fix is usually a shorter shelf life for future lots.
Class II · Moderate risk
Olopatadine HCl Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Neomycin & Polymyxin B Sulfates
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Naloxone Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Moxifloxacin HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Megestrol Acetate Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lorazepam Oral Concentrate
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lorazepam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine Hydrochloride Oral Topical Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine HCl Jelly USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine Ointment USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine 2.5% & Prilocaine 2.5% Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levofloxacin Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levofloxacin Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levofloxacin Injection 500mg/20 mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levocarnitine Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levetiracetam Oral Solution 100 mg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
IC-Green (indocyanine green for injection, USP)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Hydromorphone Hydrochloride Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
HydrALAZINE HCl Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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