Physicians Total Care Enjuvia recall — FDA D-090-2013
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than…
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than…
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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