CLASS I Drug recall · Reported 7 Oct 2015 · FDA Enforcement Report
Prolotherapy with Phenol (Dextrose 25%, Glycerin recalled
Hartley Medical Center Pharmacy is recalling Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl, distributed in California, Nevada. The recall was initiated on 17 Aug 2015 and the FDA has classified it as Class I.
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-1829-2015
- FDA event ID
- 71990
- Recalling firm
- Hartley Medical Center Pharmacy, Long Beach, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Aug 2015
- FDA classified
- 25 Sep 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 17 Aug 2015 | Recall initiated by company | |
| 25 Sep 2015 | Classified by FDA | +39 days |
| 7 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
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
Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Where it was distributed
CA and NV
Questions about this recall
Why was it recalled?
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Which lots are affected?
Lot: RX # 323132, Exp. 10/06/2015; RX # 328690, Exp. 12/1/2015
Where was it sold?
CA and NV
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
1 other product · FDA event 71990This product is part of a recall event; the main page for the event is Prolotherapy with Phenol (Dextrose 25%, Glycerin recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Prolotherapy with Phenol (Dextrose 25%, Glycerin recalled | Hartley Medical Center Pharmacy | Sterility | CA, NV |
More recalls from Hartley Medical Center Pharmacy
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol recalled | Hartley Medical Center Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Morphine Sulfate 0.5 mg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Morphine Sulfate 10 mg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol recalled | Hartley Medical Center Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol recalled | Hartley Medical Center Pharmacy | Sterility | Nationwide |