Class II · Moderate risk
Lloyd Thyro-Tab 0.050 mg.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Fluorouracil Topical Cream USP
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
ESTEE LAUDER DayWear Sheer Tint Release
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Class III · Low risk
Major Oral Peroxide
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Class III · Low risk
Major brand Infants' Mapap
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Class II · Moderate risk
LifeGas OXYGEN COMPRESSED UN1072 USP
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
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