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Pharmaceutical Associates Inc

Pharmaceutical Associates Inc Recalls

All product recalls associated with Pharmaceutical Associates Inc.

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1761–1780 of 4747 recalls

Nystatin Oral Suspension (Pharmaceutical Associates) – Subpotent Medication (2020)

Subpotent: Out of specification for assay at the 12-month time point.

Class IIModerate

FDAJan 14, 2020Nationwide• Pharmaceutical Associates Inc

Testosterone Cypionate Injection (Sun Pharmaceutical) – Manufacturing Deviation (2020)

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Class IIModerate

FDAJan 14, 2020Nationwide• Sun Pharmaceutical Industries, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Reaction Ring Segment, SMN 11099326, UDI 0063...

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

1...87 888990 91...238

Page 89 of 238Next

FDAJan 12, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Tri-Lo-Marzia (Lupin Pharmaceuticals) – CGMP Test Deviation (2020)

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

Class IIILow

FDAJan 10, 2020Nationwide• Lupin Pharmaceuticals Inc.

Ranitidine Hydrochloride (PD-Rx Pharmaceuticals) – NDMA Contamination (2020)

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Class IIModerate

FDAJan 10, 2020AZ, CA, FL +9 more• PD-Rx Pharmaceuticals, Inc.

Roche Diagnostics Operations, Inc.: cobas infinity core, Material No. 7154003001. The device ...

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

FDAJan 7, 2020AL, AK, CA +17 more• Roche Diagnostics Operations, Inc.

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Class IIModerate

FDAJan 7, 2020Nationwide• Mylan Pharmaceuticals Inc.

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Class IIModerate

FDAJan 7, 2020Nationwide• Mylan Pharmaceuticals Inc.

Ranitidine Tablets (Preferred Pharmaceuticals) – NDMA Contamination (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAJan 7, 2020AL, AZ, CA +4 more• Preferred Pharmaceuticals, Inc

Ranitidine Tablets (Preferred Pharmaceuticals) – NDMA Contamination (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAJan 7, 2020AL, AZ, CA +4 more• Preferred Pharmaceuticals, Inc

Siemens Healthcare Diagnostics, Inc.: Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 0063...

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

FDAJan 6, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Clinical Diagnostic Solutions, Inc.: Medonic M-Series Hematology Analyzer M16S BD ABR US Pro...

A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

FDAJan 2, 2020Nationwide• Clinical Diagnostic Solutions, Inc.

Blisovi Fe 1.5/30 (Lupin) – Tablet Crumbling (2019)

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Class IIModerate

FDADec 26, 2019Nationwide• Lupin Pharmaceuticals Inc.

Sumatriptan Tablets 100mg (Sun Pharma) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Class IIModerate

FDADec 26, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Sumatriptan Tablets 50mg (Sun Pharma) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Class IIModerate

FDADec 26, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Ranitidine 150mg Tablets 130ct (AAA Pharma) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDADec 26, 2019Nationwide• AAA Pharmaceutical, Inc.

Ranitidine 150mg Tablets 24ct (AAA Pharma) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDADec 26, 2019Nationwide• AAA Pharmaceutical, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, S...

Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.

FDADec 20, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

PCA Skin Blemish Control Bar (CoValence) – Salicylic Acid Potency (2019)

Superpotent Drug: Salicylic acid content is above the firm's specification.

Class IIILow

FDADec 20, 2019AZ• Island Kinetics, Inc. d.b.a. CoValence Laboratories

Lamotrigine 100mg Tablets (Taro Pharmaceuticals) – Cross Contamination (2019)

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Class IHigh

FDADec 20, 2019Nationwide• Taro Pharmaceuticals U.S.A., Inc.