# FDA WARNING_LETTER - Bausch & Lomb Incorporated - October 02, 2012

Source: https://www.keypedia.com/records/warning_letter/bausch-lomb-incorporated/9c41ce51-d399-4c08-ac79-66b54ee5727a

> FDA WARNING_LETTER for Bausch & Lomb Incorporated on October 02, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bausch & Lomb Incorporated
- Inspection Date: 2012-10-02
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: This FDA Warning Letter, FLA-13-01, dated October 2, 2012, was issued to Bausch & Lomb, Inc. regarding their manufacture of unapproved new drugs, specifically Pilocarpine Hydrochloride Ophthalmic Solutions (0.5%, 1%, 2%, 3%, 4%, 6%).

The FDA determined these products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Consequently, their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)].

Additionally, as prescription drugs, their labeling lacks adequate directions for lay use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Since they lack approved applications, they are not exempt from this requirement, violating section 301(a) of the Act [21 U.S.C. § 331(a)].

The FDA stated it does not intend to initiate enforcement action if manufacturing ceases within 9

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## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/bausch-lomb-incorporated/be8adcb1-2ff8-4ee1-b354-75428f7b75a6

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861