Why it was recalled
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Product description
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
Lot numbers, UPCs & expiration codes
B-06324027 (AHM #E040645) Lot #: 051017V1, Exp. Date: 5/11/17
Where it was sold
NJ
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-1060-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 80 lbs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AtHome Medical, Inc.
Original FDA data
Every field from FDA enforcement report D-1060-2017, exactly as published.
Show all FDA fields
- City
- Morris Plains
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77760
- Address
- 200 The American Rd
- Code information
- B-06324027 (AHM #E040645) Lot #: 051017V1, Exp. Date: 5/11/17
- Postal code
- 07950-2449
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1060-2017
- Classification
- Class II
- Recalling firm
- AtHome Medical, Inc.
- Product quantity
- 80 lbs
- Termination date
- Apr 24, 2018
- Reason for recall
- GMP Deviations: The firm does not include an SOP for testing for out of specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
- Distribution pattern
- NJ
- Recall initiation date
- May 11, 2017
- Initial firm notification
- Visit
- Center classification date
- Aug 9, 2017