CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
Vitamin D3 Injection, 50,000 IU/mL vial recalled by Ranier's Compounding
Ranier's Compounding Laboratory is recalling Vitamin D3 Injection, 50,000 IU/mL vial, distributed in Pennsylvania. The recall was initiated on 25 Jul 2018 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-1087-2018
- FDA event ID
- 80633
- Recalling firm
- Ranier's Compounding Laboratory, Jeannette, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2018
- FDA classified
- 15 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Jul 2018 | Recall initiated by company | |
| 15 Aug 2018 | Classified by FDA | +21 days |
| 22 Aug 2018 | 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: Practices at firm may call into question the sterility of products intended 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
Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Where it was distributed
Product was distributed within the state of Pennsylvania.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Which lots are affected?
All lots within expiry
Where was it sold?
Product was distributed within the state of Pennsylvania.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 80633This product is part of a recall event; the main page for the event is Triple P (Prostaglandin/Papaverine/Phentolamine) Injection recalled.
More recalls from Ranier's Compounding Laboratory
All 15Other Vitamin D3 recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vitamin D3 for Injection, all strengths and presentations recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Vitamin D3, 25 mcg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vitamin D3 25mcg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Vitamin D3 25mcg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Vitamin D3 IN Olive Oil Sdv 100,000U/ML Inj, Injection, 100,000u/mL recalled | Key Pharmacy and Compounding Center | Sterility | Nationwide |