The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-477-2013·Announced 2013-06-05

FDA Recalls HCG Injections Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 1200un/ml MDV products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 1200un/ml MDV, 10 ml Subcutaneous products. The recall is being conducted because FDA inspection findings resulted in concerns regarding quality control processes and a lack of assurance of sterility.

The affected products are distributed nationwide. The recall includes all products within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). The quantity involved is 3 units.

Consumers who have these products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
3

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)

  • 2013 (Jan. 2013 to April 19
  • 2013).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 43 recalled by Nora Apothecary and Alternative Therapies, Inc. 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 43 products in this recall →

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