Tri-Coast Pharmacy Recalls Methylcobalamin/Folic Acid/Pyridoxine Injections
Tri-Coast Pharmacy is recalling 99 vials of compounded Methylcobalamin/Folic Acid/Pyridoxine injections due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Tri-Coast Pharmacy is recalling 99 vials of compounded Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 mL injections. The recall is being conducted because the FDA has determined there is a lack of assurance of sterility for these products.
The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide. Specific lot codes and expiration dates are listed in the official recall documentation.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 99
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)
- 06282016B (07/01/2016)
- 06212016A (06/24/2016)
- 06142016A (06/17/2016)
- 06072016E (06/10/2016)
- 06022016B (06/05/2016)
- 06022016A (06/05/2016)
- 07262016H (07/29/2016)
- 07192016A (07/22/2016)
- 07122016A (07/15/2016)
- 07082016D (07/11/2016)
- 07062016B (07/09/2016)
- 08302016B (09/03/2016)
- 08232016D (08/26/2016)
- 08162016D (08/19/2016)
- 08092016E (08/11/2016)
- 08042016F (08/07/2016)
- 09272016D (09/30/2016)
- 09272016B (09/30/2016)
- 09202016A (09/23/2016)
- 09132016A (09/16/2016)
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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