Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
Diltiazem HCl Extended-Release Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
Affected NDC
63739-0014-10
Compare with the code on your package — it is the most precise check available.
Drug: Diltiazem
- Recalling firm
- Mckesson Packaging Services
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0714-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 Mckesson Packaging Services
All 2018 recalls
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem CD
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class II · Moderate risk
RANITIDINE Tablets
Failed Stability Specifications
Class III · Low risk
Megestrol Acetate Oral Suspension
Subpotent Drug: Out of specification for assay (stability testing)
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