Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product description
BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; BACLOFEN, PRESERVATIVE FREE 3000MCG/ML INJECTABLE 40 ML; BACLOFEN, PRESERVATIVE FREE 3300MCG/ML(3.3MG/ML) INTRATHECAL 20 ML; BACLOFEN, PRESERVATIVE FREE 5000MCG/ML(5MG/ML) INTRATHECAL 40 ML (8 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
Rx #'s: 0406446, 0404313, 0381309, 0390603, 0350228, 0389240, 0365111, 0383582, 0391840, 0399130, 0372385, 0387886, 0406914
Where it was sold
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
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-1459-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 21 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Original FDA data
Every field from FDA enforcement report D-1459-2012, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62416
- Address
- 1210 SW 33rd Avenue
- Code information
- Rx #'s: 0406446, 0404313, 0381309, 0390603, 0350228, 0389240, 0365111, 0383582, 0391840, 0399130, 0372385, 0387886, 0406914
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1459-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 21 units
- Termination date
- Aug 13, 2014
- Reason for recall
- Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; BACLOFEN, PRESERVATIVE FREE 3000MCG/ML INJECTABLE 40 ML; BACLOFEN, PRESERVATIVE FREE 3300MCG/ML(3.3MG/ML) INTRATHECAL 20 ML; BACLOFEN, PRESERVATIVE FREE 5000MCG/ML(5MG/ML) INTRATHECAL 40 ML (8 DIFFERENT PRODUCTS)
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall initiation date
- May 25, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2012