Mckesson Medical-Surgical Inc. Corporate Office: EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-5

Is my product affected?

EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02

• Brand EPIPEN

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling EPI-Pen Jr 2-PAK auto-injectors (epinephrine injection 0.15 mg) distributed nationwide in the United States. The recall involves 4 cartons containing 2 auto-injectors each and was issued due to current Good Manufacturing Practice (cGMP) deviations related to temperature abuse of the product.

McKesson Medical-Surgical was unable to identify the specific lot numbers received by individual customers. The company provided distribution letters to customers that included the dates the product was distributed and the dates the affected product may have been shipped. The recall record does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 4 cartons/2 auto injectors each Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-022022-04-13
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