FDA Recall
Terminated
Historical recordClass III
Clean & 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
by Johnson & Johnson
- Reason
- Superpotent (Single Ingredient Drug): salicylic acid
- Published
- December 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Caziant (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.
by Watson Laboratories Inc
- Reason
- Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
- Published
- December 26, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
traMADOL 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.
by Caraco Pharmaceutical Laboratories, Ltd.
- Reason
- 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.
- Published
- December 12, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
by Genentech Inc
- Reason
- 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).
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
by Genentech Inc
- Reason
- 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).
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluorouracil 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.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothroid (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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyro-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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothroid (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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyro-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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothroid (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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyro-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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothroid (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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyro-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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothroid (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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyro-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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothroid (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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyro-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.
by Lloyd Inc. of Iowa
- Reason
- cGMP Deviations; does not meet in process specification requirements
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Novarel¿ (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 insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.
by Ferring Pharmaceuticals Inc
- Reason
- 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.
- Published
- December 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.
by Ranbaxy Inc.
- Reason
- Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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