The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0894-2017·Announced 2017-06-14

Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

Qualgen is recalling Estradiol 12.5 mg pellets due to CGMP deviations and a lack of quality assurance. The recall covers 4,883 pellets distributed nationwide.

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, which corresponds to a 'Severe' severity score (4) according to the rubric, as it involves a product that could cause temporary or medically reversible health consequences.

Plain-English summary

Qualgen is recalling Estradiol 12.5 mg pellets, which are sterile, subcutaneous, prescription-only products. The recall involves 4,883 pellets in 1, 12, and 30-count bottles. The affected lots are C044, C013, B150, B119, B097, and B061, with expiration dates ranging from July 2017 to March 2018.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and a lack of quality assurance. The FDA has classified this recall as Class II. The products were distributed nationwide.

Healthcare providers and patients should stop using the affected Estradiol pellets and contact their healthcare provider for further instructions. Consumers should not use the recalled product and should return it to the pharmacy or clinic where it was obtained.

The recalled product

Product
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
Manufacturer
Qualgen
Category
Drug — Prescription Pellets
Hazard
Affected units
4,883

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 (7)

  • Lot# C044
  • Exp. 03/14/18 Lot# C013
  • Exp. 07/23/17 Lot# B150
  • Exp. 12/6/17 Lot# B119
  • Exp. 10/18/17 Lot# B097
  • Exp. 09/14/17 Lot# B061
  • Exp. 07/5/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Qualgen 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 8 products in this recall →

Related recalls

Same manufacturer · Qualgen

See all →

Same hazard · cgmp deviation

See all →

Similar recalls