The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-966-2013·Announced 2013-09-18

FDA Recalls Compounded HCG Vials Due to Sterility Assurance Concerns

Beacon Hill Medical Pharmacy is recalling compounded HCG vials because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

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 injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., is recalling H.C.G. (Compounded) vials in 5,000, 8,000, 10,000, 11,000, and 12,000 unit presentations. These sterile, prescription-only injectable vials are intended for intravenous and subcutaneous use only. The recall covers specific lots identified in the source data, which were distributed nationwide in the United States.

The recall was initiated following FDA inspectional findings that resulted in concerns associated with quality control procedures. These findings specifically impacted the assurance of sterility for the compounded products. The agency classification for this recall is Class II.

Consumers and healthcare providers who have these specific vials should stop using them and contact their pharmacist or the recalling firm for instructions on return or disposal. The recall is limited to the specific lot codes listed in the official recall notice.

The recalled product

Product
H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Manufacturer
Beacon Hill Medical Pharmacy, P.C.
Category
Drug — Compounded Injectable
Hazard

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)

  • 01242013@23
  • 03132013@20
  • 04232013@21
  • 06112013@31
  • 03282013@24
  • 02042013@9
  • 03092013@6
  • 04122013@10
  • 04232013@24
  • 05232013@8
  • 06192013@26
  • 07102013@18
  • 07132013@6
  • 01072013@3
  • 02192013@10
  • 04172013@23
  • 06192013@28
  • 07102013@15
  • 07132013@8
  • 03232013@4

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →

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