Medicine recalls
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| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of multiple ophthalmic products |
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The US Food and Drug Administration (FDA) announces that Altaire Pharmaceuticals, Inc., is voluntarily recalling the prescription drug products and lots, within expiry, as indicated below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed. No other lots are being recalled.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including sterility testing, for the products.
Product descriptions:
- Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, NDC number: 0574-4250-35; Lot number: SAC, SLK
- NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment, NDC number: 0574-4160-35; Lot number: RGC, RHB, RHC, RID, RIC, RIG, RKH, RKI, RKJ, RKK, RKL, RLM, SAI, SBG, SBH, SCF, SEA, SFA, SFB, SHA, SIB, SJC, TAB, TAF, TBP, TBQ, TCV, TCW
- NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment, NDC number: 0574-4144-35; Lot number: SEE, SEG, SIE, SKD
- POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment, NDC number: 0574-4021-35; Lot number: RGD, RHL, RHB, RJF, RJG, SAJ, SAK, SAL, SAM, SBK, SHE, TCD
- Bacitracin Ophthalmic Ointment, NDC number: 0574-4022-35; Lot number: RGA, RGE, RGG, RGH, RHM, RJB, RJA, SCA, SIC, TAP, TDE
- Sulfacetamide Sodium Ophthalmic Ointment, NDC number: 0574-4190-35; Lot number: RID, SHG
- Puralube Ophthalmic Ointment, NDC number: 0574-4025-35, Lot number: RJH, SCC, SGA, SGH, SHH, SLL, TAC; and with NDC number: 0574-4025-20, Lot number: RKM, SGA, SIF, SKE
The products are manufactured and labeled exclusively for Perrigo Company PLC. Altaire ships the products only to Perrigo Company PLC. The products are distributed by Perrigo Company PLC. Altaire has notified Perrigo by e-mail on July 2, 2019 announcing the recalls of the products/lots, with specific directions for return of all units of the impacted lots. Altaire has also requested that Perrigo perform a subrecall, and that Perrigo notify its customers.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Thursday, Jul 4, 2019
Issued at HKT 16:00
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