FDA Recall
Terminated
Historical recordClass II
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85
by The Harvard Drug Group
- Reason
- Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940
by PD-Rx Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
by C. O. Truxton
- Reason
- Labeling: Label Mixup; potentially mislabeled
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
by C. O. Truxton
- Reason
- Labeling: Label Mixup; potentially mislabeled
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
by C. O. Truxton
- Reason
- Labeling: Label Mixup; potentially mislabeled
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
by C. O. Truxton
- Reason
- Labeling: Label Mixup; potentially mislabeled
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10
by C. O. Truxton
- Reason
- Labeling: Label Mixup; potentially mislabeled
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
by C. O. Truxton
- Reason
- Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Grandma's Herbs
- Product
- "Because They Work" GRANDMA'S HERBS CHOLESTEROL SUPPORT, Die…
- Reason
- Grandmas Herbs Cholesterol has undeclared soy lecithin.
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Commonwealth Dairy, Llc
- Product
- Friendly Farms Key Lime Crunch Tilts Greek Lowfat Yogurt, 5.…
- Reason
- Recalling Friendly Farms Key Lime Crunch Tilts because it may contain undeclared almond pieces.
- Published
- August 30, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
by AVKARE Inc.
- Reason
- Failed impurities/degradation specifications: Out of specification for a related compound C.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202
by Lupin Limited (Unit 1)
- Reason
- Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
by Genetic Edge Compounds LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
by ICU Medical Inc
- Reason
- Presence of Particulate Matter; stainless steel
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
by Akorn Inc
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
by Akorn Inc
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
by Akorn Inc
- Reason
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
by DYNAMIC TECHNICAL FORMULATIONS
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
by HARDCORE FORMULATIONS
- Reason
- Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- Published
- August 23, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
by HARDCORE FORMULATIONS
- Reason
- Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- Published
- August 23, 2017
- 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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