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.
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Failed Stability Specifications
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Failed Impuities/Degradation Specifications
Failed Impuities/Degradation Specifications
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Stability Data Does Not Support Expiry
Stability Data Does Not Support Expiry
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
Stability data does not support expiry.
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