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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 601–620 of 1,000 recalls

Class IIITerminated

Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

June 12, 2018 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

June 12, 2018 · DrugView details →

Class IIITerminated

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Qualgen, LLC

Labeling: Incorrect or Missing Lot and/or Exp Date.

June 8, 2018 · DrugView details →

Class IIITerminated

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Qualgen, LLC

Labeling: Incorrect or Missing Lot and/or Exp Date.

June 8, 2018 · DrugView details →

Class IIITerminated

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01

Mylan Pharmaceuticals Inc.

Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

June 7, 2018 · DrugView details →

Class IIITerminated

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

Pharmaceutical Associates Inc

Resuspension problems: Out of specification for appearance and resuspendability.

May 29, 2018 · DrugView details →

Class IIITerminated

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90

Jubilant Cadista Pharmaceuticals, Inc.

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

May 25, 2018 · DrugView details →

Class IIITerminated

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

LUPIN SOMERSET

Labeling: Missing Label

May 24, 2018 · DrugView details →

Class IIITerminated

T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

Milbar Laboratories, Inc.

Subpotent

May 4, 2018 · DrugView details →

Class IIITerminated

Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

Milbar Laboratories, Inc.

Subpotent

May 4, 2018 · DrugView details →

Class IIITerminated

Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

Teva Pharmaceuticals USA

Failed Stability Specifications

April 30, 2018 · DrugView details →

Class IIITerminated

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

Sun Pharmaceutical Industries, Inc.

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

April 26, 2018 · DrugView details →

Class IIITerminated

Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10

Mckesson Packaging Services

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

April 23, 2018 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Mckesson Packaging Services

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

April 23, 2018 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10

Mckesson Packaging Services

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

April 23, 2018 · DrugView details →

Class IIITerminated

Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45

Rhodes Pharmaceuticals, L.P.

Failed Dissolution Specification: Low dissolution outside of specifications

April 17, 2018 · DrugView details →

Class IIITerminated

OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10

Septodont Inc.

Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.

April 13, 2018 · DrugView details →

Class IIITerminated

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

Boiron Inc.

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

April 13, 2018 · DrugView details →

Class IIITerminated

Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00

Aidarex Pharmaceuticals LLC

Presence of Foreign Tablets/Capsules

April 10, 2018 · DrugView details →

Class IIITerminated

Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478

Pharmedium Services, LLC

cGMP deviations

April 10, 2018 · DrugView details →

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