Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Sterility Concerns
Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA sampling found microorganisms in the production clean room.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in intrathecal drugs, which poses a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling three specific sterile intrathecal drug mixtures: HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML, HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML, and HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML. The recall covers 7 units of these 18 mL products.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This finding indicates a lack of assurance of sterility for the affected drugs.
The affected products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies between November 21, 2011, and May 21, 2012. Specific prescription numbers associated with the recall are N0391871, N0395248, N0400014, N0404731, N0404936, N0408940, and N0387888. Patients and healthcare providers should contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT…
- Category
- Drug — Sterile Intrathecal
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #'s:N0391871 N0395248 N0400014 N0404731 N0404936 N0408940 N0387888
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 100 products in this recall →Related recalls
Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab
See all →- SevereFranck's Lab Recalls Sterile Methylcobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereRecall of Sterile Ophthalmic Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Lidocaine/Tetracaine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Compounding Lab Recalls Sterile Leucovorin Vials Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
Same hazard · microbial contamination
See all →- SevereGreenwich Rx Recalls Glutathione Injection Due to Microbial Contamination
FDA (Drugs) · 2026-10-28
- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- SevereFranck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Compounding Lab Recalls Sterile Ophthalmic Drug Mixtures
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Verapamil Injectable Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereRecall of Mepivacaine Injectable Due to Sterility Assurance Failure
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Levofloxacin Injectable Due to Sterility Concerns
FDA (Drugs) · 2012-08-22