Class I · High risk Terminated
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Reason Non-Sterility: failed sterility test result.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk Terminated
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk…
Reason Defective delivery system: detached needles on the syringe in the kit.
Class I · High risk Terminated
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in…
Reason Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Class I · High risk Terminated
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO…
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk Terminated
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus…
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk Terminated
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II…
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk Terminated
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured…
Reason Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class I · High risk Terminated
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection…
Reason Non Sterility; contaminated with Klebsiella pneumoniae
Class I · High risk Terminated
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services…
Reason Non-Sterility; microbial contamination identified as Bacillus circulans
Class I · High risk Terminated
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further…
Reason Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class I · High risk Terminated
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes…
Reason Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Class I · High risk Terminated
Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister…
Reason Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen…
Class I · High risk Terminated
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories…
Reason Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Class I · High risk Terminated
Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as…
Class I · High risk Terminated
Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as…
Class I · High risk Terminated
Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as…
Class I · High risk Terminated
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as…
Class I · High risk Terminated
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk Terminated
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Reason Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Class I · High risk Terminated
PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix…
Reason Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10…
Class I · High risk Terminated
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Reason Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class I · High risk Terminated
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC…
Reason Non-Sterility: fungal contamination due to leaking containers.
Class I · High risk Terminated
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA…
Reason Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class I · High risk Terminated
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV…
Reason Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Class I · High risk Terminated
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port…
Reason Presence of Particulate Matter: identified as dried skin.