Class II · Moderate risk
Domperidone 10 mg capsules
Lack of Processing Controls.
Domperidone BP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.
Affected NDCs
52372-0898-01
52372-0898-02
52372-0898-03
52372-0898-04
Compare with the code on your package — it is the most precise check available.
Drug: Domperidone
- Recalling firm
- Freedom Pharmaceuticals Inc
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0567-2016 · 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 I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
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 Freedom Pharmaceuticals Inc
All 2015 recalls
Class II · Moderate risk
Baclofen USP powder
Presence of Foreign Substance
Class III · Low risk
5-methyltetrahydrofolate Calcium
Subpotent Drug
Other cross-contamination recalls from 2015
All cross-contamination recalls
Class II · Moderate risk
Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg)
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Class II · Moderate risk
Mupirocin Calcium Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
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