Teva Pharmaceuticals USA Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count recall — FDA D-0100-2019
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Overview of recall records associated with Teva Pharmaceuticals USA, including dates, categories and classifications where available.
Classification mix: Class II: 120, Class III: 23, Class I: 4.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside…
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
This page summarizes recall records in which the official source identifies Teva Pharmaceuticals USA 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.