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
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
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.
Class II · Moderate risk
remifentanil HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
neostigmine Methylsulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
neostigmine Methylsulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
neostigmine Methylsulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.