FDA: Not all Eli Lilly products covered by recall order

The Food and Drug Administration on Friday said certain products from pharmaceutical firm Eli Lilly may still be sold, citing a stay order from the office of Health Secretary Enrique Ona.

In Advisory 2014-043 dated May 30, the FDA said the following products, which have valid product registration, are allowed in the Philippine market:

• Gemzar 200mg Powder for IV Injection, DR-XY40364
• Humulin 70/30 Vial, DR-XY14545
• Humulin N Vial, DR-XY6181
• Humulin R Vial, DR-XY6180
• Humulin 70/30 Cartridge, DR-XY23452
• Humulin N Cartridge, DR-XY23454
• Zyprexa 5mg Tablet, DR-XY22855
• Zyprexa 10mg Tablet, DR-XY22856
• Alimta 100mg Lyophilized Powder for Intravenous Infusion, DR-XY35204
• Alimta 500mg Lyophilized Powder for I.V. Infusion, DR-XY31536
• Gemzar 1g Powder for Injection, DR-XY42100
• Cymbalta 60mg Capsule, DR-XY41867
• Zyprexa Zydis 5mg Tablet, DR-XY37273
• Forteo 250mcg/mL Solution for Injection, DR-XY29234
• Byetta 250mcg/mL Solution for Injection (1.2mL) SC, DR-XY33256
• Byetta 250mcg/mL Solution for Injection (2.4mL) SC, DR-XY33264
• Effient 5mg Film-Coated Tablet, DR-XY37670
• Effient 10mg Film-Coated Tablet, DR-XY37671
• Cymbalta 30mg Capsule, DR-XY31173
• Zyprexa Zydis 10mg Orodispersible Tablet, DR-XY37455

Earlier this month, the FDA fined the pharmaceutical firm P16 million for importing and distributing unregistered products.

FDA also ordered the recall of 15 Eli Lilly Philippines products after finding they were either unregistered or had falsified product registrations.

Covered by the recall order were:

• Cialis 20 mg Tablet
• Cymbalta 30mg Capsule
• Humalog 100 units per mL Solution for Injection
• Humalog Kwikpen 100u/mL Solution for Injection
• Humalog Mix 25 Kwikpen 100iu per mL Solution For Injection
• Humalog Mix 25
• Humalog Mix 50 Kwikpen
• Stratterra 10mg Capsule
• Stratterra 18mg Capsule
• Stratterra 25mg Capsule
• Straterra 40 mg Capsule
• Strattera 60mg Capsule
• Prozac 20mg Capsule
• Zyprexa Zydis 10mg Orodispersible tablet
• Zyprexa Intramascular 20mg Powder for Injection

Dr. Kenneth Hartigan-Go, FDA director,  said at the time that only the following Eli Lilly products have a certificate of product registration:

• Alimta 100mg Lyophilized Powder for Intravenous Infusion, FDA registration number DR-XY35204
• Alimta 500mg Lyophilized Powder for I.V. Infusion, DR-XY31536
• Gemzar 1g Powder for Injection, DR-XY42100
• Cymbalta 60mg Capsule, DR-XY41867
• Zyprexa Zydis 5mg Tablet, DR-XY37273
• Forteo 250mcg/mL Solution for Injection, DR-XY29234
• Byetta 250mcg/mL Solution for Injection (1.2mL) SC, DR-XY33256
• Byetta 250mcg/mL Solution for Injection (2.4mL) SC, DR-XY33264
• Effient 5mg Film-Coated Tablet, DR-XY37670
• Effient 10mg Film-Coated Tablet, DR-XY37671