Why it was recalled
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Product description
UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
Lot numbers, UPCs & expiration codes
Lot # K411517501, K411517601, K411517701, K411518001, K411518101, K411518201, K411518202, K411518301, K411518302, K411518701, K411518801, K411518901, K411518902, K411519001, K411519101, K411519401, K411519501, K411519601, K411519602, K411519701, K411519801, K411520101, K411520201, K411520301, K411520302, K411520401, K411520901, K411521001, K411521002, K411521101, K411521102, K411521201, K411521501, K411521601, K411521602, K411521701, K411521702, K411521801, K411521901, K411522201, K411522301, K411522401, K411522501, K411523001, K411523101, K411523201, K411523202, K411523301, K411523601, K411523701, K411523801, K411523901, K411523902, K411524001, K411524301, K411524302, K411524401, K411522601, K411522901,
Where it was sold
Nationwide
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-0783-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 16, 2015
- FDA report date
- Apr 6, 2016
- Quantity
- 382 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Praxair Inc.
Original FDA data
Every field from FDA enforcement report D-0783-2016, exactly as published.
Show all FDA fields
- City
- Danbury
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 72252
- Address
- 39 Old Ridgebury Road
- Code information
- Lot # K411517501, K411517601, K411517701, K411518001, K411518101, K411518201, K411518202, K411518301, K411518302, K411518701, K411518801, K411518901, K411518902, K411519001, K411519101, K411519401, K411519501, K411519601, K411519602, K411519701, K411519801, K411520101, K411520201, K411520301, K411520302, K411520401, K411520901, K411521001, K411521002, K411521101, K411521102, K411521201, K411521501, K411521601, K411521602, K411521701, K411521702, K411521801, K411521901, K411522201, K411522301, K411522401, K411522501, K411523001, K411523101, K411523201, K411523202, K411523301, K411523601, K411523701, K411523801, K411523901, K411523902, K411524001, K411524301, K411524302, K411524401, K411522601, K411522901,
- Postal code
- 06817-0001
- Report date
- Apr 6, 2016
- Product type
- Drugs
- Recall number
- D-0783-2016
- Classification
- Class III
- Recalling firm
- Praxair Inc.
- Product quantity
- 382 cylinders
- Termination date
- May 10, 2016
- Reason for recall
- CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 16, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2016