5 More Heart and Blood Pressure Medications Recalled Nationwide

Last week’s recall on four cholesterol prescriptions now coincides with a recall on five more heart-related medications, several of which may have been produced by the same manufacturer as the cholesterol meds.

Pharmaceutical company Glenmark Pharmaceuticals Inc. initiated a nationwide recall published April 8 on 39 types of medications, approximately a quarter of which are used to treat cardiovascular-related conditions. In an update, the FDA shared the following list of drugs indicated for diagnoses involving chest pains, irregular heartbeat, and high blood pressure:

• Propafenone hydrochloride (Rythmol generic) – may be prescribed for heart arrhythmia, often known as Afib
• Nitroglycerin sublingual (Nitrostat generic) – may be administered for chest pain
• Ranolazine (Ranexa generic) – may also be administered for chest pain
• Carvedilol (Coreg generic) – may be indicated for heart failure and blood pressure
• Diltiazem hydrochloride (Cardizem generic) – may be indicated for high blood pressure and/or chest pain

In its report, the FDA shared the following identifying details pertinent to the recalled product:

Propafenone hydrochloride extended release, 225 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 60 capsules
• National Drug Code (NDC): 68462-408-60
• Lot number: 17230819
• Expiration date: Mar-25

Propafenone hydrochloride extended release, 325 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 60 capsules
• NDC: 68462-409-60
• Lot number: 17230767
• Expiration date: Mar-25

Propafenone hydrochloride extended release, 225 mg—not stated who it was manufactured for

• Amount per bottle: 60 capsules
• NDC: 16714-825-01
• Lot number: 17230819
• Expiration date: Mar-25

Propafenone hydrochloride extended release, 325 mg—not stated who it was manufactured for

• Amount per bottle: 60 capsules
• NDC: 16714-826-01
• Lot number: 17230767
• Expiration date: Mar-25

Nitroglycerin sublingual, 0.4 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 100 tablets
• NDC: 68462-639-45
• Lot number: 17232024, 17232071, or 17232072
• Expiration date: Aug-25 or Sep-25

Nitroglycerin sublingual, 0.3 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 100 tablets
• NDC: 68462-638-01
• Lot number: 17232361 or 17232367
• Expiration date: Nov-25

Ranolazine extended release, 1,000 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 60 tablets
• NDC: 68462-320-60
• Lot number: 17240040
• Expiration date: Dec-25

Carvedilol, 12.5 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 500 tablets
• NDC: 68462-164-05
• Lot number: 17240238, 17240243, 17240245, or 17240248
• Expiration date: Jan-26

Diltiazem hydrochloride extended release, 12HR, 120 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 100 capsules
• NDC: 68462-562-01
• Lot number: 17241067 or 17241628
• Expiration date: May-26 or Aug-26

According to a report issued by the U.S. Food and Drug Administration (FDA), the recall is the result of Current Good Manufacturing Practices (CGMP) deviation. CGMP standards are regulations set to ensure pharmaceutical manufacturing facilities produce quality drugs. “Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations,” the FDA’s page on CGMP states. CGMP deviations may occur due to poorly maintained equipment, lack of established inspection protocols, or “unsafe and/or ineffective drugs.”

The FDA’s report suggests Glenmark Pharmaceuticals’ voluntary recall on these and other medications first went into effect on March 13.

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