Class II · Moderate risk
CREON (pancrelipase)
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
FDA Drug Recalls
1,273 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.