Tri-Coast Pharmacy Recalls HCG/Hydroxycobalamin Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 1,304 vials of compounded HCG/Hydroxycobalamin nationwide due to a lack of assurance of sterility.
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 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a compounded drug, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 1,304 vials of HCG/Hydroxycobalamin 5,000 IU/5 mg. The recall is being conducted because there is a lack of assurance of sterility for the affected products.
The recalled products were compounded between May 17, 2016, and November 17, 2016, and were distributed nationwide. Specific lot codes and expiration dates are listed in the official recall documentation.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 1,304
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 (6)
- 07192016B (01/15/2017)
- 08262016A (01/31/2017)
- 08092016C (01/31/2017)
- 09192016C (01/31/2017)
- 11042016C (11/04/2016)
- 10252016A (02/28/2017)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by Tri-Coast Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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