The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0272-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 1,458 vials of compounded Methylcobalamin injections nationwide because the products lack 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 an injectable product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 1,458 vials of Methylcobalamin 1,000 mcg/mL, available in 10 mL and 30 mL sizes. The recall is being conducted because the products lack assurance of sterility. The affected products were compounded between May 17, 2016, and November 17, 2016, and were distributed nationwide.

The recall includes specific lot codes with expiration dates ranging from November 22, 2016, to April 11, 2017. These lots include 05312016KK, 05262016A, 060920161, 07262016B, 07062016C, 08292016B, 10132016F, 10252016K, 07262016C, and 09152016.

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
1,458

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)

  • 05262016A (11/22/2016)
  • 060920161 (12/06/2016)
  • 07262016B (01/22/2017)
  • 07062016C (12/31/2016)
  • 08292016B (02/25/2017)
  • 10132016F (04/11/2017)
  • 10252016K (02/28/2017)
  • 07262016C (01/22/2017)
  • 09152016 (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.

See all 80 products in this recall →

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