The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0249-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls BCAA Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 265 vials of compounded BCAA solution because the agency cannot ensure the products are sterile.

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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are listed, the lack of sterility assurance in a compounded drug is a significant hazard warranting a high severity rating under the Class II criteria.

Plain-English summary

Tri-Coast Pharmacy is recalling 265 vials of BCAA (30 ML) compounded solution. The product contains Isoleucine (L) 15 mg, Leucine (L) 10 mg, Valine 40 mg, and Lidocaine HCL 10 mg/mL. The recall is being conducted because there is a lack of assurance of sterility for the affected products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes and expiration dates involved in the recall are 07222016A (01/18/2017), 08162016C (02/12/2017), 08042016A (01/31/2017), 11012016I (04/30/2017), and 10172016B (02/28/2017). The products were distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Medication
Hazard
Affected units
265

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 (4)

  • 08162016C (02/12/2017)
  • 08042016A (01/31/2017)
  • 11012016I (04/30/2017)
  • 10172016B (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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