The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0267-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls L-Carnitine Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 14 vials of L-Carnitine 250 mg/mL because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.

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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).

Plain-English summary

Tri-Coast Pharmacy is recalling 14 vials of L-Carnitine 250 mg/mL (30 mL) due to a lack of assurance of sterility. The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. The known lot code is 09132016F, with an expiration date of February 28, 2017.

The products were distributed nationwide. 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, or where the probability of serious adverse health consequences is remote.

Consumers who have these products should stop using them and contact Tri-Coast Pharmacy for further instructions or a refund. Healthcare providers should verify the lot code and expiration date of any L-Carnitine 250 mg/mL vials in their inventory to ensure they are not using the recalled product.

The recalled product

Product
L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
14

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 →

Related recalls

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · lack of sterility

See all →

Similar recalls