Impax Laboratories

Initial Business Response / [redacted] (1000, 5, 2015/11/02) */ Impax Laboratories, Increceived a report from Ms [redacted] that an Impax branded product, Mixed Amphetamine Salt ER Capsules, mg, "did not work" for her son, [redacted] ***Impax reports all adverse events associated with the use of one of our products to the FDA, pursuant to applicable law, and investigates each report The company investigated Ms***'s report, but was not able to identify any problems with the manufacture of the Mixed Amphetamine Salts ER Capsules, or their handling up to the time they left the company's possessionImpax informed Ms [redacted] of its findings Ms [redacted] clarified in letters of August 5, 2015, and October 16, 2015, that her concern was not with the manufacture or handling of the productRather she contends that the company's "generic version of the Brand Adderall XR was NOT comparable to the Brand named Adderall XR her son had been taking." On November 2, 2015, Impax informed Ms [redacted] that Impax's Mixed Amphetamine Salts ER Capsules she purchased are the Authorized Generic version of the brand Adderall XR(r), manufactured by Shire LLCThe term Authorized Generics refers to prescription drugs that are approved by the Food and Drug Administration under the brand manufacturers' new drug applications and manufactured by the brand companies, in this case Shire, but marketed or sold as generics under private label, in this case Impax'sIn short, if Ms [redacted] son received Impax's Mixed Amphetamine Salts ER Capsules, he received Shire's brand Adderall XR(r) product that was packaged under Impax's label Impax does not sell products directly to patients, and the company cannot provide refundsRefund requests must be submitted to the pharmacy from which the product was purchasedOnly the pharmacy can determine whether a refund may be made based on its policies as well as the applicable laws and regulations in the state

Initial Business Response /* (1000, 5, 2015/11/02) */
Impax Laboratories, Inc. received a report from Ms. [redacted] that an Impax branded product, Mixed Amphetamine Salt ER Capsules, 15 mg, "did not work" for her son, [redacted]. Impax reports all adverse events associated with the use of one...

of our products to the FDA, pursuant to applicable law, and investigates each report.
The company investigated Ms. [redacted]'s report, but was not able to identify any problems with the manufacture of the Mixed Amphetamine Salts ER Capsules, or their handling up to the time they left the company's possession. Impax informed Ms. [redacted] of its findings.
Ms. [redacted] clarified in letters of August 5, 2015, and October 16, 2015, that her concern was not with the manufacture or handling of the product. Rather she contends that the company's "generic version of the Brand Adderall XR was NOT comparable to the Brand named Adderall XR her son had been taking."
On November 2, 2015, Impax informed Ms. [redacted] that Impax's Mixed Amphetamine Salts ER Capsules she purchased are the Authorized Generic version of the brand Adderall XR(r), manufactured by Shire LLC. The term Authorized Generics refers to prescription drugs that are approved by the Food and Drug Administration under the brand manufacturers' new drug applications and manufactured by the brand companies, in this case Shire, but marketed or sold as generics under private label, in this case Impax's. In short, if Ms. [redacted] son received Impax's Mixed Amphetamine Salts ER Capsules, he received Shire's brand Adderall XR(r) product that was packaged under Impax's label.
Impax does not sell products directly to patients, and the company cannot provide refunds. Refund requests must be submitted to the pharmacy from which the product was purchased. Only the pharmacy can determine whether a refund may be made based on its policies as well as the applicable laws and regulations in the state.