This morning I received an email alerting me of a massive recall of nearly 100 products manufactured by ETHEX Corporation. Refer to the Press Release regarding this recall at www.ETHEX.com
This may be a dumb question but, what is the difference between a recall at the wholesaler level and the retail pharmacy level? When it says at the wholeslaer level, that to me seems to mean that the pharmacy are not supposed to pull the product? But that doesn't seem right.
Why ethics could apply to your concerns, legally the recall process regulated by the FDA use a Risk/Benefit Analyst when enforcing recalls. Below are the classifications of recalls and a quick description of each, information is from the FDA's website;
Recall Classifications
These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:
Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.
I called Ethex Corp this morning with that same question and they said Hospitals would be under the retail pharmacy level. The only items at that level recalled are Hydromorphone 2mg tablets and Metoprolol ER 25, 50,100mg.