FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
The Compounding Pharmacy of America is recalling 5 vials of HCG and Methylcobalamin injection due to non-sterility. The product was distributed in Tennessee and South Carolina.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
The Compounding Pharmacy of America is voluntarily recalling 5 vials of HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection. The recall was initiated on January 12, 2018, because the product was found to be non-sterile. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected product is a 5 mL multi-dose vial, sterile, prescription-only, compounded by The Compounding Pharmacy of America in Knoxville, Tennessee. The specific lot number is 01052018@46, with a use-by date of February 9, 2018. The product was distributed in Tennessee and South Carolina.
Consumers who have this product should stop using it immediately and contact their healthcare provider or the recalling firm for instructions on disposal or return. The recall status is currently terminated.
The recalled product
- Product
- HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injection
- Hazard
- 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)
- Lot: 01052018@46 Use By: 2/9/2018
Distribution
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