Multi-event February 2017 FDA Recall Drug by Advanced Pharma Inc.

This Multi-event Class II drug recall was voluntarily initiated by Advanced Pharma Inc. on February 22, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0834-2017 TERMINATED D-0825-2017 TERMINATED D-0806-2017 TERMINATED D-0824-2017 TERMINATED D-0827-2017 TERMINATED D-0799-2017 TERMINATED D-0840-2017 TERMINATED D-0801-2017 TERMINATED D-0845-2017 TERMINATED D-0816-2017 TERMINATED D-0819-2017 TERMINATED D-0852-2017 TERMINATED D-0831-2017 TERMINATED D-0818-2017 TERMINATED D-0820-2017 TERMINATED D-0826-2017 TERMINATED D-0830-2017 TERMINATED D-0796-2017 TERMINATED D-0795-2017 TERMINATED D-0833-2017 TERMINATED D-0802-2017 TERMINATED D-0836-2017 TERMINATED D-0849-2017 TERMINATED D-0814-2017 TERMINATED D-0804-2017 TERMINATED D-0848-2017 TERMINATED D-0809-2017 TERMINATED D-0797-2017 TERMINATED D-0843-2017 TERMINATED D-0846-2017 TERMINATED D-0838-2017 TERMINATED D-0835-2017 TERMINATED D-0823-2017 TERMINATED D-0829-2017 TERMINATED D-0800-2017 TERMINATED D-0853-2017 TERMINATED D-0851-2017 TERMINATED D-0847-2017 TERMINATED D-0803-2017 TERMINATED D-0794-2017 TERMINATED D-0813-2017 TERMINATED D-0821-2017 TERMINATED D-0817-2017 TERMINATED D-0832-2017 TERMINATED D-0810-2017 TERMINATED D-0837-2017 TERMINATED D-0842-2017 TERMINATED D-0812-2017 TERMINATED D-0828-2017 TERMINATED D-0807-2017 TERMINATED D-0811-2017 TERMINATED D-0815-2017 TERMINATED D-0844-2017 TERMINATED D-0805-2017 TERMINATED D-0850-2017 TERMINATED D-0808-2017 TERMINATED D-0822-2017 TERMINATED D-0841-2017 TERMINATED D-0839-2017 TERMINATED D-0798-2017 TERMINATED

Recall Number: D-0834-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0825-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0806-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0824-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0827-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0799-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0840-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0801-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0845-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0816-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0819-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0852-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0831-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0818-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0820-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0826-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0830-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0796-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0795-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0833-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0802-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0836-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0849-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0814-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0804-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0848-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0809-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0797-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0843-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0846-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0838-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0835-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0823-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0829-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0800-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0853-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0851-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0847-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry.

Recall Number: D-0803-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0794-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0813-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0821-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0817-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0832-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0810-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0837-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0842-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0812-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0828-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0807-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0811-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0815-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0844-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0805-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0850-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0808-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-0822-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0841-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0839-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots within expiry

Recall Number: D-0798-2017

Reason for Recall
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Initiated
02-22-2017
Reported
05-31-2017
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2017
Product Description About Product Description
Full technical description of the product.
RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Batch or Lot Expiration Information

Lot# all lots