CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
Dehydrated Alcohol Solution recalled by Ranier's Compounding
Ranier's Compounding Laboratory is recalling Dehydrated Alcohol Solution, 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-1086-2018
- 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
Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, 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
Is Dehydrated Alcohol Solution recalled?
Yes. Ranier's Compounding Laboratory recalled Dehydrated Alcohol Solution on 25 Jul 2018. The recall is Class II and its status is Terminated. Recall number D-1086-2018.
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 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.