The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1163-2018·Announced 2018-09-05

Auro Pharmacies Recalls Testosterone Injectable Due to Sterility Concerns

Auro Pharmacies is recalling 43 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure 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 recall is classified as FDA Class II and involves a sterile injectable product where sterility assurance was inadequate, posing a significant risk of infection or serious injury.

Plain-English summary

Auro Pharmacies, Inc. is recalling 43 vials of Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in 3 mL and 5 mL multiple dose vials. The product was distributed nationwide in the USA. The specific lot number is 180709/21, with an expiration date of 07-Sep-18.

The recall was initiated due to a lack of assurance of sterility. The FDA determined that inadequate processes and equipment were used to assure the sterility of products intended to be sterile. This classification is designated as Class II by the FDA.

Patients who have received this specific lot of medication should contact their healthcare provider for guidance. Consumers should not use the remaining vials and should return them to the pharmacy or the recalling firm.

The recalled product

Product
Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Manufacturer
Auro Pharmacies, Inc.
Category
Drug — Injectable Sterile
Hazard
Affected units
43

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 #: 180709/21
  • Exp 07-Sep-18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Auro Pharmacies, 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 12 products in this recall →

Related recalls

Same manufacturer · Auro Pharmacies, Inc.

See all →

Same hazard · sterility failure

See all →

Similar recalls