Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
Affected NDC
70250-1860-01
Compare with the code on your package — it is the most precise check available.
Drug: Diltiazem
- Recalling firm
- Banner Pharmacy Services, LLC
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0015-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Diltiazem recalls
See all
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Other recalls by Banner Pharmacy Services, LLC
All 2017 recalls
Class II · Moderate risk
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Succinylcholine 200 mg/10 mL Syringe
Lack of Assurance of Sterility.
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