The Recall Desk
ModerateFDA (Drugs)·D-1290-2015·Announced 2015-08-12

Apothecary Shoppe Recalls HCG Injection Due to Sterility Documentation Issues

The Apothecary Shoppe is recalling HCG 1000 U/mL Injection vials because proper environmental monitoring documentation was missing during production.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a documentation issue regarding environmental monitoring rather than a confirmed contamination or reported illness, fitting the criteria for a moderate risk or voluntary precautionary recall.

Plain-English summary

The Apothecary Shoppe LLC is recalling S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vials. The recall involves 98 mL of product with Lot # 04302015@66 and a Beyond Use Date of 06/29/2015. The product was distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. The company identified that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap prevents verification that the product was manufactured in a sterile environment.

Consumers who have this specific lot of HCG injection should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80

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 (2)

  • Lot #: 04302015@66
  • BUD 06/29/2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 28 recalled by The Apothecary Shoppe LLC 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 28 products in this recall →