The Recall Desk
HighFDA (Drugs)·D-1015-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL vials because FDA inspections found GMP violations that may affect sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Testosterone Cypionate 200mg/mL, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada.

The recall was initiated after 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 illnesses or injuries associated with the use of these vials.

Patients who have received this medication should contact their healthcare provider for guidance on next steps. The recall covers specific lots with expiration dates ranging from April 2016 to July 2016.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Injectable Steroid
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 #: 01142016:19@26
  • Exp. 04/14/2016
  • Lot #: 02032016:23@32
  • Exp. 05/05/2016
  • Lot #: 02092016:17@9
  • Exp.06/10/2016
  • Lot #: 04262016: 11@16
  • Exp. 07/27/2016
  • Lot #: 01112016:65@70
  • Exp.04/10/2016
  • Lot #: 01202016:57@46
  • Exp.04/19/2016
  • 01212016:08@34
  • Exp. 04/28/2016
  • Lot: 02082016:08@27
  • Exp.05/08/2016
  • Lot #: 02222016:82@50
  • Exp.05/22/2016 03142016:75@24
  • Exp. 06/14/2016
  • Lot #: 03212016:07@73

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

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Same hazard · sterility failure

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