Class II · Moderate risk
Chorionic Gonadotropin Compounded
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
FDA Drug Recalls
1,711 recalls, newest first
Class II · Moderate risk
Chorionic Gonadotropin Compounded
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Calm Me Vitamin Cocktail
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
B1/B2/B5/B12/Lidocaine/Isoleucine/Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
B1/B2/B3/B5/B12/Lidocaine/Isoleucine/Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class III · Low risk
Verapamil Hydrochloride Extended-Release tablets
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Class II · Moderate risk
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow…
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Class III · Low risk
Phentermine Hydrochloride Capsules
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk
Allopurinol Tablets
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Class III · Low risk
buPROPion Hydrochloride Extended-¿release Tablets USP
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk
fentaNYL Citrate
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Class II · Moderate risk
lidocaine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
lidocaine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
succinylcholine Chloride Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
rocuronium Bromide
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.