Watson Laboratories Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 recall — FDA D-1053-2014
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Overview of recall records associated with Watson Laboratories Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3, Class III: 2.
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
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.
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…
This page summarizes recall records in which the official source identifies Watson Laboratories Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.