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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 5881–5900 of 17,773 recalls

Class IITerminated

Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.

The Harvard Drug Group

Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

May 22, 2020 · DrugView details →
Class ITerminated

NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.

Acella Pharmaceuticals, LLC

Superpotent Drug.

May 22, 2020 · DrugView details →
Class IIOngoing

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.

Wuhan Bingbing Pharmaceutical Co., Ltd.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

May 19, 2020 · DrugView details →
Class IIOngoing

Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.

Wuhan Bingbing Pharmaceutical Co., Ltd.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

May 19, 2020 · DrugView details →
Class IIOngoing

Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.

Wuhan Bingbing Pharmaceutical Co., Ltd.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

May 19, 2020 · DrugView details →
Class IIITerminated

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01

Flexion Therapeutics, Inc.

Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

May 19, 2020 · DrugView details →
Class IIOngoing

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.

Wuhan Bingbing Pharmaceutical Co., Ltd.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

May 19, 2020 · DrugView details →
Class IITerminated

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11

American Health Packaging

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).

May 19, 2020 · DrugView details →
Class IITerminated

Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02

TRIOVA PHARMACEUTICALS LLC

Failed impurities/ degradation specifications: Out of specification for organic impurities.

May 15, 2020 · DrugView details →
Class IITerminated

EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037.

Eco Lips Inc

Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.

May 15, 2020 · DrugView details →
Class IITerminated

Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

PD-Rx Pharmaceuticals, Inc.

Failed dissolution specifications

May 15, 2020 · DrugView details →
Class IIITerminated

Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.

InvaGen Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

May 14, 2020 · DrugView details →
Class IITerminated

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

West-Ward Columbus Inc

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

May 13, 2020 · DrugView details →
Class IIITerminated

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.

West-Ward Columbus Inc

Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.

May 13, 2020 · DrugView details →
Class IITerminated

Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

BIOTA Biosciences LLC

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

May 11, 2020 · DrugView details →
Class IITerminated

Sterile Curcumin 50mg/mL, 10 mL vial

BIOTA Biosciences LLC

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

May 11, 2020 · DrugView details →
Class IITerminated

Sterile Curcumin, 4mg/mL, 10mL vial

BIOTA Biosciences LLC

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

May 11, 2020 · DrugView details →
Class IITerminated

Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial

BIOTA Biosciences LLC

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

May 11, 2020 · DrugView details →
Class IITerminated

Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

BIOTA Biosciences LLC

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

May 11, 2020 · DrugView details →
Class IITerminated

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05

Torrent Pharma Inc.

Failed Dissolution Specifications

May 11, 2020 · DrugView details →
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