Compounding pharmacy initiates voluntary recall of trypan blue

Richfield, MN-A small compounding pharmacy near Minneapolis is recalling some lots of its trypan blue 0.06% ophthalmic solution after a customer said two patients who used it had symptoms of bacterial infection.

The recall notice, issued Aug. 26 by Custom Rx Compounding Pharmacy through the FDA, said the solution might contain Pseudomonas aeruginosa, although company owner and pharmacist Verne Betlach, RPh, FIACP, said test results had not yet shown whether that was true.

Betlach said he initiated the recall the same night he learned of the complaints.

Betlach, who said he had never advertised his drugs outside of Minnesota, said he was unsure which lots might be affected, so he is asking that all 1-ml sterile tuberculin syringes in the following lots be returned to the pharmacy: 05042005:86@17; 05252005:36@13; 06282005:91@27; 08012005:63@24; and 08182005:43@17.

"As you might imagine, my main concern is for any patient who may have been affected," Betlach said. He estimated losses associated with this recall at well under $1,000.

A pharmacist for 30 years, Betlach said the recall has been personally devastating to him. His small firm of five employees-including his wife-has never before encountered a recall.

"It's more than gut-wrenching," Betlach said. "And we don't know [results], but to have someone call and tell you that a product you [created] may have hurt somebody, that is what hurts most of all."