FDA Recall
Terminated
Historical recordClass II
Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
by Boehringer Ingelheim Roxane Inc
- Reason
- Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
- Published
- August 6, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
- Published
- August 6, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
by Mckesson Packaging Services
- Reason
- Failed Dissolution Specification; at the 12 month time interval.
- Published
- August 6, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
by Estee Lauder Inc
- Reason
- Stability Data Does Not Support Expiry
- Published
- July 30, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
by Shamrock Medical Solutions Group LLC
- Reason
- Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
- Published
- July 30, 2014
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
by Shamrock Medical Solutions Group LLC
- Reason
- Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
- Published
- July 30, 2014
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass II
Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01
by Shamrock Medical Solutions Group LLC
- Reason
- Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
- Published
- July 30, 2014
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Terminated
Historical recordClass I
metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
by Shamrock Medical Solutions Group LLC
- Reason
- Labeling: Label Mix up; product labeled did not indicated Extended Release
- Published
- July 30, 2014
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass I
Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36
by Shamrock Medical Solutions Group LLC
- Reason
- Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
- Published
- July 30, 2014
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass I
Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
by Shamrock Medical Solutions Group LLC
- Reason
- Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
- Published
- July 30, 2014
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass III
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
- Published
- July 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
- Published
- July 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70
by Pfizer Inc.
- Reason
- Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
- Published
- July 23, 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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