Class II · Moderate risk
CREON (pancrelipase)
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Class II · Moderate risk
Assured Aspirin Enteric Safety Coated Tablets
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Class II · Moderate risk
TOPIRAMATE Tablets 200 mg
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Class II · Moderate risk
Tarceva (erlotinib)
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Class II · Moderate risk
Amiodarone HCl Injection
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Class III · Low risk
MethylPREDNISolone TABLETS
Subpotent; 6 month stability time point
Class I · High risk
Heparin Sodium
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Class II · Moderate risk
Potassium Chloride Injection
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Class I · High risk
Tropi/Cyclo/Phenyl/Tobra/Flurb
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk
Magnesium Chloride 20%
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk
Glutathione 100mg/mL Sterile Injection
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk
Ascorbic Acid 500 mg/mL Sterile Injection
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class II · Moderate risk
Bupivacaine HCl Inj.
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count…
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Class II · Moderate risk
Dermatend Ultra
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Class II · Moderate risk
Dermatend Original
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Class II · Moderate risk
Fluocinonide Gel USP
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Class II · Moderate risk
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Class II · Moderate risk
OXYCODONE and ACETAMINOPHEN
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Class II · Moderate risk
Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Tri-mix T50
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.