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Showing 2501–2520 of 3363 results

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HEB Loratadine Orally Disintegrating Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Sunmark Loratadine Tablets (Ohm Labs) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

CVS Pharmacy Loratadine Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Class IIILow

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Safeway Loratadine Tablets (Ohm Labs) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Leader Loratadine Orally Disintegrating Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Up&Up Loratadine Orally Disintegrating Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Major Loratadine Orally Disintegrating Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Equaline Loratadine Tablets (Ohm Labs) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Hydralazine Injection (Fresenius Kabi) – Incorrect Expiration (2015)

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

FDAJul 28, 2015Nationwide• Fresenius Kabi USA, LLC

Discount Drug Mart Loratadine (Ohm Labs) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Wal-itin Loratadine Orally Disintegrating Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

TopCare Loratadine Tablets (Ohm Labs) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Good Neighbor Pharmacy Loratadine Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Health Best Choice Loratadine Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

CareOne Allergy Relief Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Nisoldipine Extended Release 17mg (Shionogi) – dissolution failure (2015)

Failed Dissolution Specifications

FDAJul 24, 2015Nationwide• Shionogi Inc.

Phentermine Capsules 15mg (PD-Rx) – impurity specification (2015)

Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station

FDAJul 21, 2015Nationwide• PD-Rx Pharmaceuticals, Inc.

Verapamil Extended-Release 240mg (Apotex) – dissolution failure (2015)

Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.

FDAJul 21, 2015Nationwide• Apotex Inc.

Allopurinol Tablets 300mg (Qualitest) – tablet specification issue (2015)

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

FDAJul 20, 2015Nationwide• Qualitest Pharmaceuticals

Bupropion Hydrochloride Tablets (Sun Pharma) – dissolution failure (2015)

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

FDAJul 17, 2015Nationwide• Sun Pharma Global Fze

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