Class II · Moderate risk
Saluta (reduced glutathione)
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
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
Tatiomax (reduced glutathione/hydrolyzed collagen)
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Laroscorbine Platinium
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Tev-Tropin
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Class III · Low risk
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Class II · Moderate risk
Famotidine Injection 20 mg
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Class II · Moderate risk
QVAR¿ (beclomethasone dipropionate HFA)
Defective Delivery System; defective valve
Class II · Moderate risk
Liothyronine Sodium Tablets
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Class I · High risk
Atropine Sulfate 0.4 mg/ml Injection
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/ml
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Class III · Low risk
Olanzapine Orally Disintegrating Tablets 5 mg
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Class III · Low risk
Triveen - PRx RNF Capsules
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Class III · Low risk
Wockhardt Metoprolol Succinate
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Class II · Moderate risk
Pristiq (desvenlafaxine)
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Class I · High risk
Super ARTHGOLD 500mg
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Class III · Low risk
Children's Triacting Night Time Cold & Cough with PE
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.