Franck's Lab Recalls Sterile Clindamycin Eye and Injectable Products
Franck's Lab Inc. is recalling sterile clindamycin eye and injectable products due to microorganisms and fungal growth found in the 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 and involves sterile injectable and ophthalmic products with confirmed microbial contamination, which carries a significant risk of serious injury or hospitalization.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling specific sterile clindamycin products, including ophthalmic solutions and intravitreal injectables. The recall covers units distributed between November 21, 2011, and May 21, 2012.
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 lack of assurance of sterility poses a risk to patients using the products.
The affected products were distributed nationwide and in several international locations, including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS)
- Affected units
- 5
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: 0397741 0402847 0396295 0394438
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.
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