Meditech Laboratories, Inc: Superpotent Drug: one ingredient was found to be above assay specification.; Lack of Assurance of Sterility: incomplete or missing data regarding production.; Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Agency Publication Date: April 1, 2016

Affected Products

Product: Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot #: 110115-2, Exp 01/01/16

Lot Numbers:

110115-2

Product: Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

Lot#: 022316-4, Exp 04/08/16

Lot Numbers:

022316-4

Product: Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot#: 022416-9, Exp 04/09/16.

Lot Numbers:

022416-9

Product: Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16

Lot Numbers:

011916-1

Product: Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot#: 011716-3, Exp 04/17/16; 012416-3, Exp 04/24/16.

Lot Numbers:

011716-3

Product: Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot#: 020716-0, Exp 05/07/16

Lot Numbers:

020716-0

Product: Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot #: 12216-2, Exp 04/22/16

Lot Numbers:

12216-2

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73537

Status: Resolved

Manufacturer: Meditech Laboratories, Inc

Manufactured In: United States

Units Affected: 7 products (1320 vials - all formulas)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot #: 110115-2, Exp 01/01/16

Lot Numbers:

110115-2

Product: Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

Lot#: 022316-4, Exp 04/08/16

Lot Numbers:

022316-4

Lot#: 022416-9, Exp 04/09/16.

Lot Numbers:

022416-9

Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16

Lot Numbers:

011916-1

Product: Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot#: 011716-3, Exp 04/17/16; 012416-3, Exp 04/24/16.

Lot Numbers:

011716-3

Product: Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot#: 020716-0, Exp 05/07/16

Lot Numbers:

020716-0

Product: Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Lot #: 12216-2, Exp 04/22/16

Lot Numbers:

12216-2