Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 2,339 compounded Chorionic Gonadotropin Injectable Kits nationwide due to a lack of assurance of 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 (injection) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 2,339 kits of Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. Specific known kit lot codes include 04212016@49, 05262016@154, 06092016@181, 08082016@118, and 08252016@89. Known vial lot codes include 04142016@34, 05202016@55, 06032016@42, 08012016@41, and 08192016@47.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled lots. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 2,339
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 (10)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code:04212016@49
- 05262016@154
- 06092016@181
- 08082016@118
- 08252016@89. Known vial lot code: 04142016@34
- 05202016@55
- 06032016@42
- 08012016@41
- 08192016@47.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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.
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