Why it was recalled
Lack of Assurance of Sterility
Product description
Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
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-0377-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 16, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 74 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Downing Labs, LLC
Original FDA data
Every field from FDA enforcement report D-0377-2016, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72455
- Address
- 4001 McEwen Rd Suite 110
- Code information
- All lots
- Postal code
- 75244-5020
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0377-2016
- Classification
- Class II
- Recalling firm
- Downing Labs, LLC
- Product quantity
- 74 vials
- Termination date
- Sep 22, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Distribution pattern
- Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
- Recall initiation date
- Oct 16, 2015
- Initial firm notification
- Press Release
- Center classification date
- Nov 18, 2015