Why it was recalled
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Product description
LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Lot numbers, UPCs & expiration codes
LOT#: 117H201 LOT#: 117H202
Where it was sold
Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
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-1383-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 4, 2012
- FDA report date
- Jun 27, 2012
- Quantity
- 283 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Linde Gas LLC
Original FDA data
Every field from FDA enforcement report D-1383-2012, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 61917
- Address
- 7029 Huntley Rd Ste K
- Code information
- LOT#: 117H201 LOT#: 117H202
- Postal code
- 43229-1059
- Report date
- Jun 27, 2012
- Product type
- Drugs
- Recall number
- D-1383-2012
- Classification
- Class II
- Recalling firm
- Linde Gas LLC
- Product quantity
- 283 cylinders
- Termination date
- Jun 11, 2013
- Reason for recall
- CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
- Distribution pattern
- Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
- Recall initiation date
- May 4, 2012
- Initial firm notification
- Other
- Center classification date
- Jun 15, 2012