GlaxoSmithKline Recalls Sumatriptan Injection Cartridges Due to Sterility Concerns
GlaxoSmithKline is recalling 9,743 cartridges of Sumatriptan Succinate Injection because some may have needles protruding through the shield, compromising 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 agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a significant safety defect (sterility compromise) is categorized as Severe.
Plain-English summary
GlaxoSmithKline, LLC. is recalling 9,743 cartridges of Sumatriptan Succinate Injection, 6 mg, 0.5 mL. The product is intended for subcutaneous injection and is distributed nationwide. The specific lot number is C636242, with an expiration date of 06/15.
The recall was initiated due to a lack of assurance of sterility. A small number of the pre-filled syringes may contain needles that protrude through the needle shield. This defect poses a risk to the sterility of the injection.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in…
- Manufacturer
- GlaxoSmithKline, LLC.
- Category
- Drug — Injectable Medication
- Affected units
- 9,743
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#: C636242
- Exp: 06/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GlaxoSmithKline, 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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