Class II · Moderate risk
Ketamine 100 mg/mL
Stability data does not support expiry.
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
Glycopyrrolate 0.2 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Morphine Sulfate
Stability data does not support expiry.
Class II · Moderate risk
Fentanyl Citrate
Stability data does not support expiry.
Class II · Moderate risk
Midazolam
Stability data does not support expiry.
Class II · Moderate risk
Ondansetron 2 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Succinylcholine 20 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Rocuronium 10 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Phenylephrine
Stability data does not support expiry.
Class II · Moderate risk
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Cevimeline Hydrochloride Capsules
Failed Stability Specifications: product may not meet specification limit for assay test.
Class III · Low risk
Hydralazine Hydrochloride Injection
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class II · Moderate risk
lidocaine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
lidocaine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
succinylcholine Chloride Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
rocuronium Bromide
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
remifentanil HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
neostigmine Methylsulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
neostigmine Methylsulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
neostigmine Methylsulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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