Tailor Made Compounding Recalls Tesamorelin Vials Due to Incorrect Expiration Dates
Tailor Made Compounding is recalling 10,280 vials of Tesamorelin because the labels indicate a 1-year expiration date instead of the correct 6-month date.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Tailor Made Compounding is recalling 10,280 vials of Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection. The product is distributed nationwide in the United States. The recall is due to a labeling error where the vials indicate a 1-year expiration date instead of the correct 6-month expiration date.
The affected lots include specific lot and expiration codes listed in the recall notice, with expiration dates of 7/19 and 8/19. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product. Patients should consult their healthcare provider regarding alternative treatment options if necessary.
The recalled product
- Product
- Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
- Manufacturer
- Tailor Made Compounding
- Category
- Drug — Injectable
- Hazard
- Affected units
- 10,280
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 (20)
- Lot
- exp: 7101804
- 7111807
- 7131807
- 7151801
- 7161804
- 7181805
- 7191801
- 7201803
- 7211801
- 7221801
- 7231805
- 7241803
- 7251803
- 7261802
- 7271801
- 7281801
- 7301805
- 7311805
- exp 7/19
Distribution
Distributed nationwide across the United States.
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