Why it was recalled
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Product description
MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lot numbers, UPCs & expiration codes
Lot #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016: 85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016: 95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016: 01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016: 19@17 04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp. 05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016.
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-1003-2016
- 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-1003-2016, 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 #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016: 85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016: 95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016: 01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016: 19@17 04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp. 05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016.
- Postal code
- 89121-7345
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-1003-2016
- 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
- MYERS' COCKTAIL, packaged in 37 mL vials, 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