Recalls / Class I
Class ID-1829-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot: RX # 323132, Exp. 10/06/2015; RX # 328690, Exp. 12/1/2015
Why it was recalled
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Recalling firm
- Firm
- Hartley Medical Center Pharmacy, Incorporated
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 113 W Victoria St, N/A, Long Beach, California 90805-2162
Distribution
- Quantity
- 14 vials
- Distribution pattern
- CA and NV
Timeline
- Recall initiated
- 2015-08-17
- FDA classified
- 2015-09-25
- Posted by FDA
- 2015-10-07
- Terminated
- 2015-12-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1829-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.