Cetrorelix injection kits recalled over missing or duplicated needles inside
Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate for Injection kits over a defective delivery system, with needles either missing from or duplicated within the kit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites missing or duplicated needles in a kit with no stated clinical consequence or reported harm.
Plain-English summary
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, single-dose kit, Rx only, made for Meitheal Pharmaceuticals of Chicago, Illinois, under NDC 71288-558-90, is being recalled.
The reason given in the enforcement record is a defective delivery system: missing or duplicated needles within the injection kit.
The record lists 16,477 kits from lot Q4E0112A, expiry 30 Apr 2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
A kit without its needle cannot be used as supplied. The record reports no injuries. Patients should contact their prescriber or pharmacy if a kit is missing a needle rather than substituting one.
The recalled product
- Product
- CETRORELIX ACETATE (CETRORELIX ACETATE)
- Brand
- CETRORELIX ACETATE
- Manufacturer
- Meitheal Pharmaceuticals, Inc
- Category
- Drug — Fertility injection
- Affected units
- 16,477
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 Q4E0112A
- Exp.: 30 Apr 2027
Distribution
Distributed nationwide across the United States.
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