Failed Tablet/Capsule Specifications; Product contains broken tablets.
Watson Laboratories
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Class I - Dangerous
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.