CLASS II ONGOING Drug recall · Reported 17 Jul 2013 · FDA Enforcement Report
Pento-Gluc 200 mg/ml Injection recalled by Lowlite Investments
Lowlite Investments is recalling Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL, distributed nationwide in the US. The recall was initiated on 29 May 2013 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-767-2013
- FDA event ID
- 65360
- Recalling firm
- Lowlite Investments, Orlando, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2013
- FDA classified
- 11 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 29 May 2013 | Recall initiated by company | |
| 11 Jul 2013 | Classified by FDA | +43 days |
| 17 Jul 2013 | Published in enforcement report | +6 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 findings resulted in concerns regarding quality control processes
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
Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Where it was distributed
Nationwide and PR
Questions about this recall
Is Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL recalled?
Yes. Lowlite Investments recalled Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL on 29 May 2013. The recall is Class II and its status is Ongoing. Recall number D-767-2013.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which lots are affected?
B0521 Exp 8/21/13
Where was it sold?
Nationwide and PR
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.
More recalls from Lowlite Investments
All 105| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine 3 mg/ml Injection recalled by Lowlite Investments | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Voriconazole 5% Ophthalmic drop compounded by Olympia recalled | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Vitamin B-Buildup Injection, compounded by Olympia Pharmacy recalled | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Micc (Methionine, Inositol, Choline, Cyanocobalamin recalled | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Lisinopril 20 mg/ml Injection recalled by Lowlite Investments | Lowlite Investments | Sterility | Nationwide |