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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
by Actavis Laboratories, FL, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
by Actavis Laboratories, FL, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
by Sagent Pharmaceuticals Inc
- Reason
- Lack of Assurance of Sterility; leaking of premix bags
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.
by AbbVie Inc
- Reason
- Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: particulate matter was found during the manufacturing process.
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
- Published
- October 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
by Cubist Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
- Published
- October 8, 2014
- 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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