Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2013-01-02FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA
Subpotent; 9-month stability interval
- 2013-01-02FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Subpotent; 9-month stability interval
- 2013-01-02FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Subpotent; 9-month stability interval
- 2012-12-26FDA-DrugHospira, Inc.Class IILidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
- 2012-12-26FDA-DrugJohnson & JohnsonClass IIIClean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8
Superpotent (Single Ingredient Drug): salicylic acid
- 2012-12-26FDA-DrugGenentech, Inc.Class IIICellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.
Short Fill: some bottles contained less than 120-count per labeled claim.
- 2012-12-26FDA-DrugHospira, Inc.Class IINalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
- 2012-12-26FDA-DrugBracco Diagnostic IncClass IIICholetec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.
Presence of Particulate Matter; potential for charcoal particulates
- 2012-12-26FDA-DrugWatson Laboratories IncClass IIICaziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
- 2012-12-26FDA-DrugPhysicians Total Care, Inc.Class IIProcrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.
Presence of Particulate Matter: glass delamination
- 2012-12-19FDA-DrugPhysicians Total Care, Inc.Class IIIEnjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
- 2012-12-19FDA-DrugPhysicians Total Care, Inc.Class IIIEnjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
- 2012-12-19FDA-DrugPhysicians Total Care, Inc.Class IIIEnjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
- 2012-12-12FDA-DrugCaraco Pharmaceutical Laboratories, Ltd.Class IItraMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
- 2012-12-12FDA-DrugGenentech IncClass IINutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
- 2012-12-12FDA-DrugGenentech IncClass IINutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
- 2012-12-12FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIFluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugLloyd Inc. of IowaClass IIThyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
- 2012-12-12FDA-DrugFerring Pharmaceuticals IncClass IIINovarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
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