Ranitidine Injectable Recalled Due to Sterility Assurance Failures
Franck's Lab Inc. is recalling Ranitidine 25mg/mL 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, which corresponds to a Severe severity score 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 products involved are Ranitidine 25mg/mL Injectable in 200 mL, 480 mL, and 800 mL volumes.
The recall was initiated after FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This indicates a lack of assurance of sterility for the affected units.
The recalled products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Affected prescription numbers include 0398569, 0399778, and 0398076. Patients and healthcare providers should stop using these products and contact their healthcare provider for further instructions.
The recalled product
- Product
- RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable
- Affected units
- 3
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: 0398569 0399778 0398076
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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