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Showing 121–133 of 133 results

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Tranexamic Acid Injection (AuroMedics) – metal contamination (2022)

Presence of Particulate Matter: Piece of metal found in a vial

FDASep 26, 2022Nationwide• AuroMedics Pharma LLC

Timolol Maleate Eye Solution (Akorn) – Unknown Impurity (2022)

Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.

FDAAug 8, 2022Nationwide• Akorn, Inc

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Defective Container: Tube split from side seam

Class III

FDAJul 11, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Aspirin Dipyridamole Capsules (Glenmark) – Capsule Breakage (2022)

Failed Tablet/Capsule Specification : Capsule breakage

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Butalbital APAP Caf Tablets (Bryant Ranch) – Incomplete Labeling (2021)

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

FDASep 28, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Methylprednisolone Tablets (DocRx) – Illegible Label (2021)

Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.

FDAMar 19, 2021AL, CA, IN +1 more• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Vitamin B12 Supplement (Absonutrix) – missing ingredient (2018)

The firm was informed that the product did not contain vitamin B12 (Methylcobalamyn) as listed on the label.

FDAJun 11, 2018AL, CA, FL +19 more• Absonutrix

INOVA Easy Pad (Cipher Pharmaceuticals) – Subpotent Formulation (2016)

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

FDADec 6, 2016AZ, CO, OH• Cipher Pharmaceuticals US LLC

Ramipril Capsules (Actavis) – Incorrect Expiration Date (2016)

Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.

FDAAug 30, 2016Nationwide• Actavis Laboratories, FL, Inc.

Magnesium Sulfate Injection (Hospira) – pH Specification Failure (2016)

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

FDAMar 23, 2016Nationwide• Hospira Inc.

Quelicin Injection (Hospira) – Labeling Defect (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

FDAMar 15, 2016Nationwide• Hospira Inc.

Normosol-M (Hospira) – Incorrect Expiration Date (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

FDAFeb 2, 2016Nationwide• Hospira Inc.

Amidate Etomidate Injection (Hospira) – impurity degradation (2015)

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

FDASep 29, 2015Nationwide• Hospira Inc.

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