Why it was recalled
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Product description
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
Lot numbers, UPCs & expiration codes
Lot # P411517501, P411517601, P411517701, P411518001, P411518101, P411518201, P411518202, P411518301, P411518701, P411518801, P411518901, P411519101, P411519401, P411519601, P411519602, P411519701, P411520101, P411520301, P411520401, P411520901, P411521001, P411521002, P411521101, P411521201, P411521501, P411521601, P411521701, P411521801, P411521901, P411522201, P411522401, P411522501, P411522901, P411523001, P411523101, P411523201, P411523301, P411523601, P411523701, P411523801, P411523901, P411524001, P411524301,
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-0782-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 16, 2015
- FDA report date
- Apr 6, 2016
- Quantity
- 127 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Praxair Inc.
Original FDA data
Every field from FDA enforcement report D-0782-2016, 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 # P411517501, P411517601, P411517701, P411518001, P411518101, P411518201, P411518202, P411518301, P411518701, P411518801, P411518901, P411519101, P411519401, P411519601, P411519602, P411519701, P411520101, P411520301, P411520401, P411520901, P411521001, P411521002, P411521101, P411521201, P411521501, P411521601, P411521701, P411521801, P411521901, P411522201, P411522401, P411522501, P411522901, P411523001, P411523101, P411523201, P411523301, P411523601, P411523701, P411523801, P411523901, P411524001, P411524301,
- Postal code
- 06817-0001
- Report date
- Apr 6, 2016
- Product type
- Drugs
- Recall number
- D-0782-2016
- Classification
- Class III
- Recalling firm
- Praxair Inc.
- Product quantity
- 127 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, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 16, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2016