FDA Recall
Terminated
Historical recordClass II
Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
by Pallimed Solutions
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- August 21, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
by Pallimed Solutions
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- August 21, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
by American Health Packaging
- Reason
- Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
- Published
- August 14, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
by Actavis Inc
- Reason
- Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
- Published
- August 14, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
by Sandoz Incorporated
- Reason
- Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
- Published
- August 14, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
by Apotex Inc
- Reason
- Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
- Published
- August 14, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
by Hospira, Inc.
- Reason
- Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
- Published
- August 14, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
by GlaxoSmithKline, LLC.
- Reason
- Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
- Published
- August 14, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
by Novartis Consumer Health
- Reason
- Defective container: products are packaged in pouches which may not have been fully sealed
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02
by Novartis Consumer Health
- Reason
- Defective container: products are packaged in pouches which may not have been fully sealed
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers
by Novartis Consumer Health
- Reason
- Defective container: products are packaged in pouches which may not have been fully sealed
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.
by Novartis Consumer Health
- Reason
- Defective container: products are packaged in pouches which may not have been fully sealed
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
by Teva Pharmaceuticals USA, Inc.
- Reason
- Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
by Sanofi US
- Reason
- Subpotent drug: low fill volume in some of the capsules
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
- Published
- August 14, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
by Reumofan Plus USA
- Reason
- Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
- Published
- August 14, 2013
- 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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