Class II · Moderate risk
Anastrozole USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Amitriptyline HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Azelastine HCl Nasal Solution
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Class II · Moderate risk
Dry to Normal Skin Starter Kit
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Day Cream SPF15 Cr¿me de jour FPS 15
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class II · Moderate risk
INFeD (Iron Dextran Injection USP)
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Class III · Low risk
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets
Failed Stability Specifications
Class III · Low risk
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Failed Stability Specifications
Class III · Low risk
Enalapril Maleate Tablets
Failed Stability Specifications
Class II · Moderate risk
Neostigmine Methylsulfate
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Class II · Moderate risk
NitroGlycerin
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
VenomX
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
StaphWash+Plus+ Skin Protectant
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
StingMed Insect bites Skin Protectant. Zinc acetate
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
Diabecline brand Topical Ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
TetraStem brand Topical Ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I · High risk
Mibelas 24 Fe
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Class III · Low risk
Benzonatate capsules
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class III · Low risk
PrednisoLONE Oral Solution USP
Failed Stability Specifications
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
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