Franck's Lab Recalls Prednisolone Acetate Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Prednisolone Acetate 10mg/ml Injectable because FDA testing 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from non-sterile injectable drugs.
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 Prednisolone Acetate 10mg/ml Injectable, 10 mLs. The recall was initiated due to a lack of assurance of sterility.
The FDA conducted environmental sampling in the clean room where sterile products were prepared and revealed the presence of microorganisms and fungal growth. This contamination raises concerns about the safety and sterility of the affected injectable medications.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 1
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 #: 0404272
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 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.
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