Class I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Domperidone 10 mg capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
Affected NDC
0507-2011-00
Compare with the code on your package — it is the most precise check available.
Drug: Domperidone
- Recalling firm
- Duren Health Mart Pharmacy
- NDC code
- 00507-2011-00
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0421-2019 · 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 Domperidone recalls
See all
Class II · Moderate risk
Domperidone BP
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Class II · Moderate risk
Domperidone active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Duren Health Mart Pharmacy
All 2018 recalls
Class II · Moderate risk
Progesterone 100 mg SR capsules
Lack of Processing Controls.
Class II · Moderate risk
Promethazine Gel 50 mg/mL
Lack of Processing Controls.
Class II · Moderate risk
Testosterone 0.1% cream
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 10% cream
Lack of Processing Controls.
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