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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA Enforcement Reports) in the United States due to the presence of glass-like particulates. These products are primarily used in cataract surgery and related ophthalmic procedures, administered as a single intraocular injection at the end of surgery to control inflammation, prevent infection, and manage postoperative pain.
These products are technically unapproved drug products under USFDA regulations, as they do not have an NDA, ANDA, or OTC Monograph approval. They are compounded under Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The product labelling explicitly states:
“This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.”
Recalled Products:
The presence of glass particulates in intraocular injections can result in serious ocular adverse effects, including severe intraocular inflammation, increased intraocular pressure, retinal or vascular injury, sterile endophthalmitis-like reactions, and potential vision loss.
Despite being one of the most regulated pharmaceutical markets globally, for historical reasons the United States allow or tolerate certain drug products that lack FDA approval, without deeming them illegal.
Key categories of Unapproved but not illegal drug products include:
In 1938, the US Congress passed the Federal Drugs and Cosmetics Act (FD&C Act) requiring all new drugs to be approved for safety. Drugs approved by USFDA between 1938 and 1962 were evaluated for safety but not efficacy. Further following the 1962 Kefauver–Harris Amendments, FDA initiated the Drug Efficacy Study Implementation (DESI) program to consider effectiveness of drugs which were earlier only approved for safety. However, some products approved between 1938-1962 continue to be marketed without NDAs/ANDAs until FDA enforcement action. Examples include certain oral phenobarbital products. Another example is colchicine which remained unapproved until an NDA was approved in 2009.
These are drug products which were in market prior to 1938 and has same label conditions of use as it was prior to passage of the 1938 FD&C Act, and composition has not changed since 1962 (that is, composition remains same as before the 1962 amendments become effective). Examples include certain Nitroglycerin medications, sublingual tablets, capsules
Drugs that are compounded by pharmacies against patient specific prescription (503A) and compounded drugs produced by FDA registered facilities in large batches and without need for individual prescriptions (503B). The Dexamethasone, Moxifloxacin formulations involved in the current recall falls under this section 503B category
OTC products marketed under the pre-final OTC Monograph system and considered GRASE (Generally Recognized as Safe and Effective) pending monograph finalization. Examples include certain sunscreen products containing zinc oxide or titanium dioxide.
Unapproved drugs temporarily allowed to address public-health needs, such as shortages or lack of approved alternatives and where risk is considered low and well understood. Examples include imported IV saline bags during shortages and certain diagnostic or imaging agents.
FDA may allow limited importation of foreign-approved drugs during shortages or public-health emergencies under specific authorization.
The 2013 amendment to the FD&C Act / Drug Quality and Security Act (DQSA) addressed compounding of drug formulations by facilities registered as Outsourcing Facilities (OFs). These facilities must comply with current Good Manufacturing Practice (cGMP) requirements under 21 CFR Parts 210 and 211.
Under Section 503B:
503B compounded drugs are exempt from FDA approval requirements under Section 505 (NDA/ANDA) and certain labelling provisions under Section 502, but labelling must clearly state that the product is a compounded drug and not FDA-approved. The compounding must be performed by or under the direct supervision of a licensed pharmacist. These drugs are also exempt from Section 582 drug supply chain security requirements.
Unlike conventional drug manufacturers (NDA/ANDA/OTC) who are allowed to advertise, brand, mass distribute drugs, the 503B compounded drugs shall not be marketed or promoted. The 503B OFs shall not produce drugs that are essentially copies of approved products and also not compound drugs withdrawn for safety of efficacy reasons. The OFs shall supply the 503B compounded drugs only to healthcare facilities, not through retail channels
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