FDA Recall
TerminatedTerminated: September 15, 2016Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
by Jubilant Cadista Pharmaceuticals Inc.
- Reason
- Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 20, 2014Historical recordClass II
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 21, 2014Historical recordClass II
Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8,
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 21, 2014Historical recordClass II
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 21, 2014Historical recordClass II
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 14, 2017Historical recordClass II
Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
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
TerminatedTerminated: March 14, 2017Historical recordClass II
Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007.
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
TerminatedTerminated: March 14, 2017Historical recordClass II
Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005
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
TerminatedTerminated: March 14, 2017Historical 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
View recall →
FDA Recall
TerminatedTerminated: March 14, 2017Historical 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
View recall →
FDA Recall
TerminatedTerminated: March 14, 2017Historical 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
TerminatedTerminated: March 14, 2017Historical 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
TerminatedTerminated: March 14, 2017Historical 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
TerminatedTerminated: March 14, 2017Historical 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
TerminatedTerminated: May 29, 2015Historical 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
View recall →
FDA Recall
TerminatedTerminated: June 3, 2015Historical 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
View recall →
FDA Recall
TerminatedTerminated: April 27, 2017Historical 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
View recall →
FDA Recall
TerminatedTerminated: November 19, 2015Historical 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
View recall →
FDA Recall
TerminatedTerminated: July 10, 2017Historical 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
TerminatedTerminated: October 7, 2015Historical 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 →
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.
Read the full medical disclaimer.