FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated May 12, 2016

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…

SOS Telecom Inc. D-0104-2017

Class I · High risk Terminated May 12, 2016

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…

SOS Telecom Inc. D-0103-2017

Class I · High risk Terminated May 12, 2016

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…

SOS Telecom Inc. D-0102-2017

Class I · High risk Terminated May 12, 2016

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…

SOS Telecom Inc. D-0101-2017

Class I · High risk Terminated Apr 29, 2016

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.

Making It a Lifestyle D-0221-2017

Class I · High risk Terminated Apr 29, 2016

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.

Making It a Lifestyle D-0220-2017

Class I · High risk Ongoing Apr 2, 2016

Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions…

Reason Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

Complete Pharmacy and Medical Solutions LLC D-0918-2017

Class I · High risk Terminated Mar 30, 2016

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…

QuVa Pharma, Inc. D-1066-2016

Class I · High risk Terminated Mar 25, 2016

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

Reliable Rexall-A Compounding Pharmacy D-1068-2016

Class I · High risk Terminated Mar 25, 2016

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.

B. Braun Medical Inc NDC 00264-1510-32 D-0094-2017

Class I · High risk Ongoing Mar 23, 2016

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per…

Reason Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

Hospira Inc. NDC 0409-2168-02 D-1137-2016

Class I · High risk Ongoing Mar 18, 2016

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045…

Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Hospira Inc. NDC 0409-6625-02 D-0865-2016

Class I · High risk Terminated Mar 9, 2016

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.

Teva Pharmaceuticals USA NDC 0703-9040-01 D-0859-2016

Class I · High risk Terminated Feb 11, 2016

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.

Pharmakon Pharmaceuticals NDC 45183-0322-78 D-0871-2016

Class I · High risk Terminated Jan 21, 2016

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.

Baxter Healthcare Corp. NDC 0338-1123-04 D-0864-2016

Class I · High risk Terminated Jan 21, 2016

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product…

Reason Presence of Particulate Matter: identified as a cloth fiber.

Baxter Healthcare Corp. NDC 0338-1055-48 D-0863-2016

Class I · High risk Terminated Jan 21, 2016

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…

Reason Presence of Particulate Matter: identified as cardboard.

Baxter Healthcare Corp. NDC 0338-0553-18 D-0862-2016

Class I · High risk Terminated Jan 15, 2016