FDA Drug Recalls

63 recalls · Class I, newest first

Apr 29, 2016 Class I · High risk

BLACK LABEL X capsules

Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.

Terminated Chemical / undeclared Making It a Lifestyle D-0220-2017

Apr 2, 2016 Class I · High risk

Human Chorionic Gonadotropin

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

Ongoing Microbial contamination Complete Pharmacy and Medical Solutions LLC D-0918-2017

Mar 30, 2016 Class I · High risk

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 mL (40 mcg/ml) on the light protective overwrap of each syringe.

Terminated Labeling / mix-up QuVa Pharma, Inc. D-1066-2016

Mar 25, 2016 Class I · High risk

Cap-Biotin 100 Mg

Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine

Terminated Labeling / mix-up Reliable Rexall-A Compounding Pharmacy D-1068-2016

Mar 25, 2016 Class I · High risk

5% Dextrose Injection USP

Non-Sterility: fungal contamination due to leaking containers.

Terminated Sterility / contamination B. Braun Medical Inc NDC 00264-1510-32 D-0094-2017

Mar 23, 2016 Class I · High risk

Magnesium Sulfate Inj.

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

Ongoing Particulate / foreign matter Hospira Inc. NDC 0409-2168-02 D-1137-2016

Mar 18, 2016 Class I · High risk

8.4% Sodium Bicarbonate Injection

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

Ongoing Particulate / foreign matter Hospira Inc. NDC 0409-6625-02 D-0865-2016

Mar 9, 2016 Class I · High risk

Amikacin Sulfate injection USP

Presence of Particulate Matter: particulate matter identified as glass in one vial.

Terminated Particulate / foreign matter Teva Pharmaceuticals USA NDC 0703-9040-01 D-0859-2016

Feb 11, 2016 Class I · High risk

Morphine Sulfate 0.5 mg/mL

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

Terminated Wrong potency / content Pharmakon Pharmaceuticals NDC 45183-0322-78 D-0871-2016

Jan 21, 2016 Class I · High risk

CLINIMIX E 5/15 sulfite-free

Presence of Particulate Matter: identified as dried skin.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-1123-04 D-0864-2016

Jan 21, 2016 Class I · High risk

Metronidazole Injection USP

Presence of Particulate Matter: identified as a cloth fiber.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-1055-48 D-0863-2016

Jan 21, 2016 Class I · High risk

0.9% Sodium Chloride Injection USP

Presence of Particulate Matter: identified as cardboard.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0553-18 D-0862-2016

Jan 15, 2016 Class I · High risk

Licorice Coughing Liquid

Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.

Terminated Chemical / undeclared Master Herbs, Inc./Li NDC 68511-0460-01 D-0908-2016

Jan 9, 2016 Class I · High risk