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Showing 4021–4040 of 14370 results

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Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Bupivacaine Hydrochloride Injection (Baxter) - Particulate Matter (2020)

Presence of particulate matter in solution - black and transparent particles

Class IIModerate

FDAOct 7, 2020Nationwide• Baxter Healthcare Corporation

Desflurane Liquid (eVenus) - Container Leak (2020)

DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.

FDAOct 6, 2020CO• eVenus Pharmaceutical Laboratories

Metformin HCL ER (PD-Rx Pharmaceuticals) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 6, 2020AK, AZ, CA +13 more• PD-Rx Pharmaceuticals, Inc.

Metformin HCL ER (PD-Rx Pharmaceuticals) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 6, 2020AK, AZ, CA +13 more• PD-Rx Pharmaceuticals, Inc.

Hydromorphone-Bupivacaine Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Fentanyl-Bupivacaine HCL Injectable (Med Shop) - Non-Sterility (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Morphine-Bupivacaine Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Sufentanil-Bupivacaine-Baclofen Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Bupivacaine HCL-Baclofen Injectable (Med Shop) - Non-Sterility (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Catapres (Boehringer Ingelheim) - Dissolution Testing Issue (2020)

An extraneous peak was observed for dissolution testing.

Class IIModerate

FDAOct 5, 2020Nationwide• Boehringer Ingelheim Pharmaceuticals, Inc.

Morphine-Hydromorphone-Bupivacaine Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Hydromorphone-Bupivacaine-Baclofen Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Hydromorphone-Bupivacaine-Sufentanil Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Bupivacaine-Lioresal Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Morphine-Bupivacaine-Ketamine Injectable (Med Shop Total Care) – Non-Sterile (2020)

Non-Sterility

FDAOct 5, 2020TX, PR• Med Shop Total Care Inc.

Catapres 0.3mg (Boehringer Ingelheim) – Dissolution Peak (2020)

An extraneous peak was observed for dissolution testing.

Class IIModerate

FDAOct 5, 2020Nationwide• Boehringer Ingelheim Pharmaceuticals, Inc.

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