FDA Recall
Terminated
Historical recordClass III
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
by Valeant Pharmaceuticals International
- Reason
- Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
by Gyma Laboratories Of Amer,Inc
- Reason
- cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
by Gyma Laboratories Of Amer,Inc
- Reason
- cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
by Gyma Laboratories Of Amer,Inc
- Reason
- cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
by Gyma Laboratories Of Amer,Inc
- Reason
- cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
by Hospira Inc.
- Reason
- Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
by Avella of Deer Valley, Inc.
- Reason
- Crystallization: Formation of crystals observed in product.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
by Zydus Pharmaceuticals USA Inc
- Reason
- Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
- Published
- October 22, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01
by Bracco Diagnostic Inc
- Reason
- Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1
by Gilead Sciences, Inc.
- Reason
- Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
All sterile products within expiry
by Unique Pharmaceutical, Ltd
- Reason
- Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
by Unique Pharmaceutical, Ltd
- Reason
- Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
by VistaPharm, Inc.
- Reason
- Defective Container: Product leaks when inverted.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
by Astellas Pharma US Inc
- Reason
- Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
by Zydus Pharmaceuticals USA Inc
- Reason
- Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
by Janssen Ortho L.L.C.
- Reason
- Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
- Published
- October 15, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.
by McKesson
- Reason
- Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
- Published
- October 15, 2014
- Distribution
- McKesson Medical-Surgical Inc distribute…
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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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