Medisca Recalls Human Chorionic Gonadotropin Due to Labeling Error
Medisca Inc. is recalling specific lots of Human Chorionic Gonadotropin (HCG) because the labels contain erroneous potency information.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Medisca Inc. is recalling 296 units of Human Chorionic Gonadotropin, EP (HCG) in 5 mu, 2 mu, and 1 mu packages. The affected products are identified by NDC codes 38779-2673-1, 38779-2673-2, and 38779-2673-6, and include lot numbers 101751/A, 101752/A, and 101799/A, all with an expiration date of 05/16.
The recall was initiated because the firm discovered erroneous potency information on the product labels. The source text does not specify the nature of the error or whether the actual product potency differs from the declared strength.
The affected products were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc.…
- Manufacturer
- Medisca Inc.
- Category
- Drug — Biological / Hormone
- Hazard
- Affected units
- 296
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 (9)
- Lot Numbers 101751/A
- Exp: 05/16
- CAS: 9002-61-3
- 101752/A
- CAS 9002-61-3
- and 101799/A
- CAS: 9002-61-3. NDC 38779-2673-1
- NDC 38779-2673-2
- and NDC 38779-2673-6.
Distribution
Distributed nationwide across the United States.
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