Drug Recalls

ATROPINE SULFATE (ATROPINE SULFATE MONOHYDRATE)

Wed Jan 08 2025

Failed Impurities/Degradation Specifications

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

Wed Jan 08 2025

Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

DAPSONE

Wed Jan 08 2025

Crystallization

NITROFURANTOIN (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS)

Wed Jan 08 2025

Failed Dissolution Specifications

Multiple Drug Recalls - AvKARE

Wed Jan 08 2025

LABELING: LABEL MIX-UP

LEVOTHYROXINE SODIUM

Wed Jan 08 2025

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Multiple Drug Recalls - Hikma Injectables USA Inc

Wed Jan 08 2025

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

CHLORPROMAZINE HYDROCHLORIDE

Wed Jan 01 2025

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 01 2025

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 01 2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

TECHNETIUM TC 99M SESTAMIBI

Wed Jan 01 2025

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

Wed Jan 01 2025

cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Jan 01 2025

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

Wed Jan 01 2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

OLANZAPINE

Wed Dec 25 2024

Failed Impurities/Degradation Specifications

Multiple Drug Recalls - Regenerative Processing Plant, LLC

Wed Dec 25 2024

Lack of Sterility Assurance

NEBIVOLOL

Wed Dec 25 2024

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)

Wed Dec 25 2024

CGMP deviations: out of specifications for assay

Multiple Drug Recalls - Keystone Industries

Wed Dec 25 2024

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

DIHYDROERGOTAMINE MESYLATE

Wed Dec 25 2024

Discoloration

LEVOTHYROXINE SODIUM

Wed Dec 18 2024

Subpotent and Superpotent Drug

TIMOLOL MALEATE

Wed Dec 18 2024

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Varithena (polidocanol injectable foam)Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3

Wed Dec 18 2024

Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

DABIGATRAN ETEXILATE

Wed Dec 18 2024

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

LEVOTHYROXINE SODIUM

Wed Dec 18 2024

Superpotent Drug and Subpotent Drug: potency failures obtained

SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL)

Wed Dec 18 2024

CGMP Deviations: Released product should have been rejected.

HYLENEX RECOMBINANT (HYALURONIDASE)

Wed Dec 18 2024

cGMP Deviations: Temperature excursion

JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)

Wed Dec 18 2024

Failed Impurities/Degradation Specifications: The observed impurity level was 0.15%, exceeding the specification limit of not more than 0.12%.

ESOMEPRAZOLE MAGNESIUM

Wed Dec 11 2024

Labeling: Not Elsewhere Classified - Wrong NDC number

10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.

Wed Dec 11 2024

CGMP Deviations: Inconsistency in the water systems.

SUNITINIB MALATE

Wed Dec 11 2024

Labeling: Label Mix-Up

VENOFER (IRON SUCROSE)

Wed Dec 11 2024

Presence of Particulate Matter: Potential for glass delamination from the vials.

CINACALCET

Wed Dec 11 2024

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Multiple Drug Recalls - Boulla LLC

Wed Dec 11 2024

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

DILTIAZEM HYDROCHLORIDE

Wed Dec 11 2024

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Dec 11 2024

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Multiple Drug Recalls - Midlab Incorporated

Wed Dec 11 2024

cGMP Deviations: Out of specification results for micro in hand soap products.

LEVOTHYROXINE SODIUM

Wed Dec 11 2024

Subpotent drug

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Dec 11 2024

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

LISDEXAMFETAMINE DIMESYLATE

Wed Dec 11 2024

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

CINACALCET

Wed Dec 11 2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Multiple Drug Recalls - Unexo Life Sciences Private Limited

Wed Dec 04 2024

cGMP Deficiencies

Multiple Drug Recalls - Neogen Corporation

Wed Dec 04 2024

CGMP violations.

PAIN RELIEF (MENTHOL, UNSPECIFIED FORM)

Wed Dec 04 2024

cGMP Deviations

RAMIPRIL

Wed Nov 27 2024

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

XELSTRYM (DEXTROAMPHETAMINE)

Wed Nov 27 2024

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

CHEST CONGESTION RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN)

Wed Nov 27 2024

Failed Impurity/Degradation Specifications

Multiple Drug Recalls - Safecor Health, LLC

Wed Nov 27 2024

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

IBU (IBUPROFEN)

Wed Nov 27 2024

Failed Tablet/Capsule Specifications

LISINOPRIL

Wed Nov 27 2024

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.