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SafetyAlerts
November 7, 2000

Faulding Pharmaceutical Recalls Morphine Sulfate Injection

Aguadilla, Puerto Rico (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Faulding Pharmaceutical PR, Inc. is recalling certain Morphine Sulfate Injection because the product is labeled to contain 0.1% sodium bisulfite rather than the actual amount of 0.2%.

This is the first public notice of this Class III issued by FDA.

PRODUCT
Morphine Sulfate Injection, USP (with additive), Rx for the relief of severe pain:
a) 1 MG/ML, NDC 61703-219-75 (30 ML (LONG) X 1 VIAL)
NDC 61703-219-80 (10 ML X 1 VIAL)
NDC 61703-219-85 (30 ML (SHORT) X 1 VIAL)

b) 5 MG/ML NDC 61703-221-75 (30 ML (LONG) X 1 VIAL)
NDC 61703-221-85 (30 ML (SHORT) X 1 VIAL)

c) 10MG/ML NDC 61703-231-32 (10 ML X 10 VIALS)
d) 25 MG/ML NDC 61703-223-21 (20 ML X 10 VIALS)

NDC 61703-223-43 (40 ML X 10 VIALS)

e) 50 MG/ML NDC 61703-225-21 (20 ML X 10 VIALS)
NDC 61703-225-43 (40 ML X 10 VIALS).

Recall #D-003/007-1.

CODE
LOT NO.   EXP. DATE

8151 9/00
8151039 11/00
8152-33, 36, 37 10/00
8152-38 11/00
8153-29, 32 9/00
8153-35 10/00
81510-31 9/00
9151-1, 1A 12/00
9151-9 3/01
9151-15, 21, 25 4/01
9151-26 7/01
9151-32, 35 8/01
9151-46, 56 10/01
9151-57, 59 11/01
9152-4, 7 2/01
9152-11, 12, 13 3/01
9152-23, 24 4/01
9152-34, 36 8/01
9152-48 10/01
9152-62 11/01
9153-3 1/01
9153-10, 14 3/01
9154-8 3/01
9154-50 10/01
9156-42 9/01
9157-33 8/01
9157-43 10/01
9157-58 11/01
9158-18 4/01
9159-5 2/01
9159-16, 20 4/01
9159-22 5/01
9159-28 7/01
9159-31 8/01
9159-38, 39, 40 9/01
9159-49 10/01
9159-51, 52, 61 11/01
91510-2, 6 1/01
91510-17, 19 4/01
91510-29 6/01
91510-30 8/01
91510-37, 41, 44, 45 9/01
91510-53, 54 10/01
91519-55 11/01
0151-4, 5 12/01
0151-21, 23, 24 2/02
0152-9, 10, 16 1/02
0152-25 2/02
0152-28, 31 3/02
0153-1 12/01
0153-12 1/02
0155-22 2/02
0156-2 12/01
0156-17 1/02
0157-6 12/01
0157-29 3/02
0158-7 12/01
0159-3, 8 12/01
0159-11, 13 1/02
0159-32, 33 4/02
01510-19, 20 2/02.

MANUFACTURER
Faulding Pharmaceutical PR, Inc., Aguadilla, Puerto Rico.

RECALLED BY
Manufacturer, by letter mailed on September 12, 2000, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 285,343 units were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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