Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 2,264 Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of 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, which corresponds to a Severe severity score under the rubric for significant injury or risk of harm.
Plain-English summary
Wells Pharmacy Network LLC is recalling 2,264 Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kits. The recall is being conducted because of a lack of assurance of sterility in the compounded product. The kits were prepared between February 22, 2016, and September 14, 2016, and are distributed nationwide.
The affected products include all lot codes prepared within the specified dates that are within their expiry. Specific known kit lot codes include 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, and 09122016@138. Known vial lot codes include 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, and 09062016@44.
Consumers and healthcare providers should stop using the recalled kits and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 2,264
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 (12)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 04152016@149
- 05182016@176
- 06172016@142
- 07272016@83
- 08232016@32
- 09122016@138. Known vial lot code: 04072016@91
- 04262016@27
- 05272016@41
- 07192016@29
- 08192016@18
- 09062016@44.
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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