Why it was recalled
Presence of Foreign Substance
Product description
Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.
Lot numbers, UPCs & expiration codes
Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016
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-0573-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2015
- FDA report date
- Jan 27, 2016
- Quantity
- (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Freedom Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0573-2016, exactly as published.
Show all FDA fields
- City
- Broken Arrow
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 72854
- Address
- 801 W New Orleans St
- Code information
- Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016
- Postal code
- 74011-1844
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0573-2016
- Classification
- Class II
- Recalling firm
- Freedom Pharmaceuticals Inc
- Product quantity
- (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers
- Termination date
- Dec 23, 2016
- Reason for recall
- Presence of Foreign Substance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 9, 2015
- Initial firm notification
- Telephone
- Center classification date
- Jan 19, 2016