CLASS II Drug recall · Reported 2 Jun 2021 · FDA Enforcement Report
Pravachol 40mg recalled by Cardinal Health
Cardinal Health is recalling Pravachol 40mg 90, distributed in Florida, Georgia, South Carolina. The recall was initiated on 15 Mar 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0460-2021
- FDA event ID
- 87512
- Recalling firm
- Cardinal Health, Dublin, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2021
- FDA classified
- 24 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 15 Mar 2021 | Recall initiated by company | |
| 24 May 2021 | Classified by FDA | +70 days |
| 2 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product as listed by the FDA
PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
Where it was distributed
FL, GA, SC
Questions about this recall
Is Pravachol 40mg 90 recalled?
Yes. Cardinal Health recalled Pravachol 40mg 90 on 15 Mar 2021. The recall is Class II and its status is Terminated. Recall number D-0460-2021.
Why was it recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which lots are affected?
ABA4203A1
Where was it sold?
FL, GA, SC
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |