Class I - Dangerous
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Samantha Lynn
Class I - Dangerous
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class I - Dangerous
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Class I - Dangerous
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Vintage Pharmaceuticals LLC
Class I - Dangerous
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I - Dangerous
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Dr. Reddy's Laboratories
Class I - Dangerous
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class I - Dangerous
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
New England Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
New England Compounding Center
Class I - Dangerous
GMP Deviations
Class I - Dangerous
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
Ben Venue Laboratories
Class I - Dangerous
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class I - Dangerous
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.