PRODUCT RECALL RETURN RESPONSE
Acknowledgment and Receipt Form
Response is Required
ALBUTEROL SULFATE INHALATION SOLUTION, 0.083%
NDC# 0487-9501-25
1.
On October 10, 2013, Nephron Pharmaceuticals Corporation, initiated a nationwide recall for ten (10)
impacted lots associated with the following product: Albuterol Sulfate Inhalation Solution, 0.083%,
NDC# 0487-9501-25. This recall was initiated as a precautionary measure due to results associated
with an aseptic process simulation at our manufacturing facility. This voluntary recall is being issued to
remove, from the market, certain lots of Albuterol Sulfate Inhalation Solution, 0.083%, that are potentially
affected.
2.
The table below indicates those lots that have been potentially impacted by this recall. Please immediately
remove, discontinue use or cease distribution of any Albuterol Sulfate Inhalation Solution, 0.083% lots that
are identified in the table below.
PRODUCT DESCRIPTION
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
Albuterol Sulfate Inhalation Solution, 0.083%
IMPACTED LOT NUMBER(S)
A3A33A
A3A33B
A3A34A
A3A35A
A3A36A
A3A37A
A3A38A
A3A40A
A3A41A
A3A42A
•
The Albuterol Sulfate Inhalation Solution, 0.083% carton contains 25 vials of product packaged in
foil overwrap. The Albuterol Sulfate Inhalation Solution, 0.083% carton is depicted below:
•
The lot numbers may be identified on the side panel of the Albuterol Sulfate Inhalation Solution,
0.083%, carton.
If you have any questions, please contact Jerry Webb at 800-443-4313 ext. 8200 or
[email protected]
Page 1 of 4
PRODUCT RECALL RETURN RESPONSE
Acknowledgment and Receipt Form
Response is Required
3.
Please return all recalled product to the following address listed below:
Nephron Pharmaceuticals Corporation
ATTN: PRODUCT RECALL
QUALITY UNIT
78 Spruce St.
Murray, KY 42071
The completed Return Response Form may be delivered via fed-ex, e-mail or fax. Please indicate the
intended method of delivery below.
□ DIRECT DELIVERY
Nephron Pharmaceuticals
Corporation
ATTN: PRODUCT RECALL
QUALITY UNIT
78 Spruce St.
Murray, KY 42071
□ E-MAIL
[email protected]
□ FAX
Nephron
Pharmaceuticals
Corporation
ATTN: PRODUCT
RECALL
QUALITY UNIT
407-849-0929
Please note, this form must be completed in its entirety and returned to Nephron Pharmaceuticals
Corporation. Completion and return of the Return Response Form is required even if there is no
current inventory of the recalled product to be returned. To ensure and confirm receipt of all
completed Return Response Forms and recalled product, please contact FedEx at 1-800-463-3339
to schedule a pickup via Express and bill to recipient using the following FedEx account number;
FedEx account number: 492168742.
4.
Any reported adverse events associated with the recalled product? □ Yes □ No
If yes, please explain:
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
_________________________________________________________________________________
If you have any questions, please contact Jerry Webb at 800-443-4313 ext. 8200 or
[email protected]
Page 2 of 4
PRODUCT RECALL RETURN RESPONSE
Acknowledgment and Receipt Form
Response is Required
5.
Please indicate the quantity of product being returned for each impacted lot:
NDC
NUMBER
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
0487-9501-25
6.
PRODUCT DESCRIPTION
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
Albuterol Sulfate Inhalation
Solution, 0.083%
LOT
NUMBER
A3A33A
QUANTITY RETURNED
to NPC
A3A33B
□ N/A
A3A34A
□ N/A
A3A35A
□ N/A
A3A36A
□ N/A
A3A37A
□ N/A
A3A38A
□ N/A
A3A40A
□ N/A
A3A41A
□ N/A
A3A42A
□ N/A
□ N/A
Please check all applicable boxes.
□ I have read and understand the recall instructions provided.
□ I have inspected my current stock and quarantined inventory consisting of impacted product. Please state
the amount of product in inventory currently ___________________ <cartons, cases, etc.
Note: This recall is a voluntary recall that extends to the Retail level. If you are contacted by a customer,
who received product impacted by this recall, please direct the customer to discontinue use immediately
and discard the affected product.
7.
Please indicate the contact information of the individual responsible for completing this Return Response
Form.
First and Last Name (Print):__________________________________
Date: _________________
Title/Position:_____________________________________________
Company/Business Name:______________________________________________________________
Address: ____________________________________________________________________________
Phone Number:_____________________________
Fax Number:___________________________
If you have any questions, please contact Jerry Webb at 800-443-4313 ext. 8200 or
[email protected]
Page 3 of 4
PRODUCT RECALL RETURN RESPONSE
Acknowledgment and Receipt Form
Response is Required
I certify that, to the best of my knowledge, the information provided in the completed Return Response
Form is true and correct.
Signature:________________________________________
Date:_______________
If you have any questions, please contact Jerry Webb at 800-443-4313 ext. 8200 or
[email protected]
Page 4 of 4