Why it was recalled
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Product description
Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
Lot numbers, UPCs & expiration codes
PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
Where it was sold
FL
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-1385-2012
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 10, 2010
- FDA report date
- Jun 27, 2012
- Quantity
- 540 tablets (9 containers of 60 tablets each)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc
Original FDA data
Every field from FDA enforcement report D-1385-2012, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 61233
- Address
- 12515 E 55th St Ste 100
- Code information
- PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
- Postal code
- 74146-6234
- Report date
- Jun 27, 2012
- Product type
- Drugs
- Recall number
- D-1385-2012
- Classification
- Class I
- Recalling firm
- Physicians Total Care, Inc
- Product quantity
- 540 tablets (9 containers of 60 tablets each)
- Termination date
- Jul 24, 2012
- Reason for recall
- Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
- Distribution pattern
- FL
- Recall initiation date
- Nov 10, 2010
- Initial firm notification
- FAX
- Center classification date
- Jun 18, 2012