FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk Terminated Sep 5, 2014

Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Reason Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be…

Pharmacy Creations D-0305-2015

Class I · High risk Terminated Aug 8, 2014

CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist…

Reason Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.

Cubist Pharmaceuticals, Inc. NDC 67919-011-01 D-0229-2015

Class I · High risk Terminated Aug 7, 2014

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only…

Reason Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Baxter Healthcare Corp. NDC 0941-0457-05 D-1610-2014

Class I · High risk Terminated Aug 1, 2014

CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington…

Reason Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.

Cubist Pharmaceuticals, Inc. NDC 67919-011-01 D-0001-2015

Class I · High risk Terminated Jul 29, 2014

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve…

Reason Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass…

Hospira Inc. NDC 0409-2066-05 D-0020-2015

Class I · High risk Terminated Jul 24, 2014

Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an…

Reason Non-Sterility: The recalled lot failed sterility testing.

Physician Preferred Medical, LLC D-0982-2015

Class I · High risk Terminated Jul 18, 2014

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

Reason Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

Unique Pharmaceutical, Ltd D-0011-2015

Class I · High risk Terminated Jul 11, 2014

Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation…

Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Baxter Healthcare Corp. NDC 0338-0703-41 D-1593-2014

Class I · High risk Terminated Jul 11, 2014

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

Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Baxter Healthcare Corp. NDC 0338-0553-18 D-1592-2014

Class I · High risk Terminated Jul 11, 2014

0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b)…

Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Baxter Healthcare Corp. NDC 0338-0049-41 D-1591-2014

Class I · High risk Terminated Jul 10, 2014

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045…

Reason Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

Hospira Inc. NDC 0409-7929-09 D-0392-2015

Class I · High risk Terminated Jul 1, 2014

Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging…

Reason Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets…

American Health Packaging NDC 62584-143-01 D-1590-2014

Class I · High risk Terminated Jul 1, 2014

Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health…

Reason Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets…

American Health Packaging NDC 68084-0703-01 D-1589-2014

Class I · High risk Terminated Jun 25, 2014

Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.

Reason Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.

Pharmacy Creations D-1546-2014

Class I · High risk Terminated Jun 17, 2014

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake…

Reason Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and…

Hospira Inc. NDC 0409-1560-29 D-0002-2015

Class I · High risk Terminated Jun 2, 2014

Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc…

Reason Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.

Alexion Pharmaceuticals, Inc. NDC 25682-001-01 D-1512-2014

Class I · High risk Terminated May 28, 2014

LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. D-1562-2014

Class I · High risk Terminated May 28, 2014

adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. D-1561-2014

Class I · High risk Terminated May 28, 2014

del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. D-1560-2014

Class I · High risk Terminated May 28, 2014

PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason Non Sterility; microbial contamination identified as Aspergillus species

Central Admixture Pharmacy Services, Inc. D-1559-2014

Class I · High risk Terminated May 12, 2014

COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb…

Reason Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials

Bristol-Meyers Squibb NDC 0590-0324-96 D-1595-2014

Class I · High risk Terminated May 12, 2014

0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015

Reason Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes

Baxter Healthcare Corp. D-1550-2014

Class I · High risk Terminated May 5, 2014

AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining…

Reason Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Eugene Oregon, Inc. D1612-2014

Class I · High risk Terminated May 5, 2014

MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663

Reason Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Eugene Oregon, Inc. D-1614-2014

Class I · High risk Terminated May 5, 2014

Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.

Reason Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Eugene Oregon, Inc. D-1613-2014