Why it was recalled
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Product description
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Lot numbers, UPCs & expiration codes
Lot: RX # 321608, Exp. 11/01/2015
Where it was sold
CA and NV
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1830-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 17, 2015
- FDA report date
- Oct 7, 2015
- Quantity
- 10 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hartley Medical Center Pharmacy, Incorporated
Original FDA data
Every field from FDA enforcement report D-1830-2015, exactly as published.
Show all FDA fields
- City
- Long Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 71990
- Address
- 113 W Victoria St
- Code information
- Lot: RX # 321608, Exp. 11/01/2015
- Postal code
- 90805-2162
- Report date
- Oct 7, 2015
- Product type
- Drugs
- Recall number
- D-1830-2015
- Classification
- Class I
- Recalling firm
- Hartley Medical Center Pharmacy, Incorporated
- Product quantity
- 10 vials
- Termination date
- Dec 30, 2015
- Reason for recall
- Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
- Distribution pattern
- CA and NV
- Recall initiation date
- Aug 17, 2015
- Initial firm notification
- Press Release
- Center classification date
- Sep 25, 2015