Why it was recalled
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Product description
GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lot numbers, UPCs & expiration codes
Lot #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp 04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016
Where it was sold
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-0985-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 869 Units (Total All Products)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Well Care Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-0985-2016, exactly as published.
Show all FDA fields
- City
- Las Vegas
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 74187
- Address
- 3430 E Tropicana Ave Ste 9
- Code information
- Lot #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp 04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016
- Postal code
- 89121-7345
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0985-2016
- Classification
- Class II
- Recalling firm
- Well Care Compounding Pharmacy
- Product quantity
- 869 Units (Total All Products)
- Termination date
- Jan 13, 2017
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Distribution pattern
- NV
- Recall initiation date
- May 17, 2016
- Initial firm notification
- Press Release
- Center classification date
- Jun 9, 2016