Franck's Lab Recalls Sterile Chromium Picolinate Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile chromium picolinate injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failure leading to infection) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the risk is significant.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific product identified in the recall notice is Chromium Picolinate 200mcg/mL Injectable 60 mL. 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.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. The recall covers 4 units associated with prescription numbers 0353549 and 0398279.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
- Category
- Drug — Sterile Injectable
- Affected units
- 4
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: 0353549 0398279
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 →- 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
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereFranck's Lab Recalls Sterile Lithium Chloride Injectable Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Selenium Injectable Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Rubidium Injectable Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Paclitaxel Injectable Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Injectable Drugs Due to Contamination
FDA (Drugs) · 2012-08-22