The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-370-2013·Announced 2013-05-22

Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.

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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in injectable drugs is categorized as Severe (Score 4), as it implies a potential for serious adverse health consequences even if not explicitly reported as hospitalizations in the provided text.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling all strengths and presentations of Human Chorionic Gonadotropin (HCG) Injection. The recall includes specific products such as HCG 1000u/mL, HCG 1000u/mL 10mL, HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, HCG Kit 1 Day w/ Drug, HCT 750u/0.75 mL Pre-Filled Syringe, HCG Syringe 150iu/0.15 mL, HCG 1500u/1.5 mL Pre-Filled Syringe, and HCG 5000 unit/5 mL vial. The affected units total 5,255 vials and syringes and were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes used by the facility. Specific lot numbers identified in the recall include 20130319-E (Exp 5/19/2013) for HCG 1000u/mL and 20130221-J (Exp 4/21/2013) for HCG 1000u/mL 10mL.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider for guidance. 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.

The recalled product

Product
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Compounded Drug
Hazard
Affected units
5,255

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 (4)

  • Lot #: a) HCG 1000u/mL: 20130319-E
  • Exp 5/19/2013
  • b) HCG 1000u/mL 10mL: 20130221-J
  • Exp 4/21/2013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs 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 78 products in this recall →

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