FDA Recall
TerminatedTerminated: April 11, 2017Historical 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
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FDA Recall
TerminatedTerminated: November 14, 2013Historical 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
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FDA Recall
TerminatedTerminated: November 14, 2013Historical 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
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FDA Recall
TerminatedTerminated: November 14, 2013Historical 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
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FDA Recall
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
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FDA Recall
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: November 14, 2013Historical 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
TerminatedTerminated: May 30, 2014Historical 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
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FDA Recall
TerminatedTerminated: April 28, 2014Historical 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 →
FDA Recall
TerminatedTerminated: April 28, 2014Historical recordClass II
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90
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 →
FDA Recall
TerminatedTerminated: April 28, 2014Historical recordClass II
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90
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 →
FDA Recall
TerminatedTerminated: December 23, 2013Historical recordClass II
Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
by Procter & Gamble Co
- Reason
- Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
- Published
- December 5, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 11, 2014Historical recordClass II
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
by GlaxoSmithKline, LLC.
- Reason
- Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
- Published
- December 5, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 18, 2013Historical recordClass II
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
by Boehringer Ingelheim Roxane Inc
- Reason
- Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
- 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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