The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0261-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls HCG Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 4,884 vials of HCG 5,000 IU due to a lack of assurance of sterility. The products were distributed nationwide.

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 states the agency classification is Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe) to ensure consistency with agency risk assessments, particularly for sterile medical products where sterility failures pose significant health risks.

Plain-English summary

Tri-Coast Pharmacy is recalling 4,884 vials of HCG 5,000 IU. The recall was initiated because of a lack of assurance of sterility in the compounded medication. The affected products were distributed nationwide.

The recalled vials are identified by specific lot codes including 06222016D, 06062016C, 07192016C07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, and 11012016F. All affected products have an expiration date of 11/16.

Consumers and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions. 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
HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Medication
Hazard
Affected units
4,884

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 (12)

  • Lot codes: 06222016D
  • 06062016C
  • 07192016C07062016A
  • 08182016B
  • 08112016A
  • 08012016A
  • 09282016A
  • 09122016D
  • 10182016C
  • 11042016B
  • 11012016F
  • Exp. 11/16

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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