Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
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
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
GaviLyteTM - C PEG-3350
Failed Stability Specification; Out of specification for Osmolarity
Class III · Low risk
LEUKINE (Sargramostim)
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class III · Low risk
Lidocaine Ointment USP
Failed Stability Specifications: product did not meet viscosity results.
Class II · Moderate risk
Neomycin Sulfate Tablets
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Buprenorphine Transdermal System 5 mcg/hour
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · Moderate risk
Elitek (rasburicase)
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class III · Low risk
Extra Strength Headache Relief
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Pain Relief Maximum Strength
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class II · Moderate risk
Maximum Strength Lidocaine Cold & Hot Patch
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
Mencaine (lidocaine 4.5%, menthol 5%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class I · High risk
Ceftazidime for Injection USP and Dextrose for Injection USP
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Class II · Moderate risk
Draximage Dtpa
Failed Stability Specifications
Class II · Moderate risk
Theophylline
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Class II · Moderate risk
Potassium Phosphate
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class II · Moderate risk
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Failed Stability Specifications.
Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class II · Moderate risk
Workvie Instant Pain Relieving Roll On
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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