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Recall Observatory FDA recall evidence

Drug product

Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0336-2017

September 21, 2016

Class II

Product summary

Firm
Wells Pharmacy Network LLC
Event
Event 75289
Status
Terminated
Classification
Class II
Quantity
10 kits
Official record key
drug-enforcement:D-0336-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04052016@16, 04072016@26, 04142016@65, 05172016@105, 06062016@137, 06152016@28, 06232016@61, 07272016@56, 08192016@108, 09062016@127 Known vial lot code: 03252016@6, 03312016@1, 04042016@30, 05052016@134, 05092016@57, 06072016@32, 06172016@120, 07222016@26, 07222016@26, 08122016@3, 08252016@3.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility