CLASS II ONGOING Drug recall · Reported 9 Nov 2022 · FDA Enforcement Report
Papaverine HCL Stock Solution 30MG/ML Solution vial recalled
Pharmacy Plus is recalling Papaverine HCL Stock Solution 30MG/ML Solution vial, distributed in Alabama, Louisiana, Mississippi, Tennessee. The recall was initiated on 7 Oct 2022 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-0047-2023
- FDA event ID
- 90982
- Recalling firm
- Pharmacy Plus, Hattiesburg, MS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2022
- FDA classified
- 2 Nov 2022
- Reported
- 9 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Oct 2022 | Recall initiated by company | |
| 2 Nov 2022 | Classified by FDA | +26 days |
| 9 Nov 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Where it was distributed
AL, LA, MS, and TN
Questions about this recall
Is Papaverine HCL Stock Solution 30MG/ML Solution vial recalled?
Yes. Pharmacy Plus recalled Papaverine HCL Stock Solution 30MG/ML Solution vial on 7 Oct 2022. The recall is Class II and its status is Ongoing. Recall number D-0047-2023.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Which lots are affected?
Lot: 60552, BUD: 03/12/2023
Where was it sold?
AL, LA, MS, and TN
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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