The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0988-2016·Announced 2016-06-15

FDA Recalls 1-HCG 1000 IU/ML Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML vials because FDA inspections identified GMP violations that may impact product 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential sterility issues in injectable medications.

Plain-English summary

Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, which is a prescription-only medication. The recall involves 869 units of the product distributed in Nevada.

The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The source text does not report any specific illnesses or injuries associated with these units.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Injectable
Hazard
Affected units
869

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)

  • Lot #: 01072016: 23@28
  • Exp. 04/06/2016
  • Lot #: 01082016: 27@1
  • Exp. 04/07/2016
  • Lot #:02012016:20@39
  • Exp. 05/01/2016
  • Lot #: 02022016:07@7
  • Exp.05/02/2016
  • Lot #: 02152016:29@50
  • Exp. 05/15/2016
  • Lot #: 02292016: 40@24
  • Exp.05/29/2016
  • Lot #: 02292016: 12@42
  • Lot #: 03042016:96@9
  • Exp.06/02/2016
  • Lot #: 03082016:59@34
  • Exp.06/08/2016 03142016:65@58
  • Exp.06/12/2016
  • Lot #: 03212016: 66@2
  • Exp.06/19/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding 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 51 products in this recall →

Related recalls

Same manufacturer · Well Care Compounding Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls